Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
October 2019

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on May 07, 2024.

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
10/01/2019	VERELAN NDA #019614	SUPPL-56	VERAPAMIL HYDROCHLORIDE	SOCIETAL CDMO	Labeling	Approval
10/01/2019	MAXALT NDA #020864	SUPPL-23	RIZATRIPTAN BENZOATE	ORGANON LLC	Labeling	Approval
10/01/2019	MAXALT-MLT NDA #020865	SUPPL-24	RIZATRIPTAN BENZOATE	ORGANON	Labeling	Approval
10/01/2019	CAPASTAT SULFATE NDA #050095	SUPPL-74	CAPREOMYCIN SULFATE	EPIC PHARMA LLC	Labeling	Approval
10/01/2019	REPAGLINIDE ANDA #077571	SUPPL-8	REPAGLINIDE	SUN PHARM INDS INC	Labeling	Approval
10/01/2019	REPAGLINIDE ANDA #077571	SUPPL-12	REPAGLINIDE	SUN PHARM INDS INC	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #077665	SUPPL-12	CLOPIDOGREL BISULFATE	RISING	Labeling	Approval
10/01/2019	TRANDOLAPRIL ANDA #078438	SUPPL-15	TRANDOLAPRIL	AUROBINDO PHARMA	Labeling	Approval
10/01/2019	TRANDOLAPRIL ANDA #078438	SUPPL-16	TRANDOLAPRIL	AUROBINDO PHARMA	Labeling	Approval
10/01/2019	MONTELUKAST SODIUM ANDA #091414	SUPPL-11	MONTELUKAST SODIUM	SANDOZ INC	Labeling	Approval
10/01/2019	PROLIA BLA #125320	SUPPL-202	DENOSUMAB	AMGEN		Approval
10/01/2019	XGEVA BLA #125320	SUPPL-202	DENOSUMAB	AMGEN		Approval
10/01/2019	MONTELUKAST SODIUM ANDA #200889	SUPPL-11	MONTELUKAST SODIUM	SANDOZ INC	Labeling	Approval
10/01/2019	BIVALIRUDIN ANDA #201577	SUPPL-2	BIVALIRUDIN	DR REDDYS	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #201686	SUPPL-2	CLOPIDOGREL BISULFATE	ZYDUS LIFESCIENCES	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #201686	SUPPL-3	CLOPIDOGREL BISULFATE	ZYDUS LIFESCIENCES	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #201686	SUPPL-4	CLOPIDOGREL BISULFATE	ZYDUS LIFESCIENCES	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #201686	SUPPL-5	CLOPIDOGREL BISULFATE	ZYDUS LIFESCIENCES	Labeling	Approval
10/01/2019	CLOPIDOGREL BISULFATE ANDA #201686	SUPPL-6	CLOPIDOGREL BISULFATE	ZYDUS LIFESCIENCES	Labeling	Approval
10/01/2019	CELECOXIB ANDA #204197	SUPPL-7	CELECOXIB	APOTEX	Labeling	Approval
10/01/2019	ENTRESTO NDA #207620	SUPPL-13	SACUBITRIL; VALSARTAN	NOVARTIS PHARMS CORP	Efficacy	Approval
10/01/2019	NERLYNX NDA #208051	SUPPL-4	NERATINIB MALEATE	PUMA BIOTECH	Efficacy	Approval
10/01/2019	AZITHROMYCIN ANDA #208249	SUPPL-1	AZITHROMYCIN	CSPC OUYI	Manufacturing (CMC)	Approval
10/01/2019	CLOMIPRAMINE HYDROCHLORIDE ANDA #208632	SUPPL-1	CLOMIPRAMINE HYDROCHLORIDE	AMNEAL PHARMS CO	Labeling	Approval
10/01/2019	CELECOXIB ANDA #208833	SUPPL-2	CELECOXIB	AMNEAL PHARMS	Labeling	Approval
10/02/2019	ACARBOSE ANDA #202271	SUPPL-3	ACARBOSE	AVET LIFESCIENCES	Labeling	Approval
10/02/2019	LIDOCAINE ANDA #202346	SUPPL-12	LIDOCAINE	MYLAN TECHNOLOGIES	Labeling	Approval
10/02/2019	METHADONE HYDROCHLORIDE ANDA #207537	ORIG-1	METHADONE HYDROCHLORIDE	SPECGX LLC		Approval
10/02/2019	CLOBETASOL PROPIONATE ANDA #211191	ORIG-1	CLOBETASOL PROPIONATE	ALEMBIC		Approval
10/02/2019	CLOBETASOL PROPIONATE ANDA #211494	ORIG-1	CLOBETASOL PROPIONATE	SAPTALIS PHARMS		Approval
10/03/2019	VERELAN PM NDA #020943	SUPPL-35	VERAPAMIL HYDROCHLORIDE	SOCIETAL CDMO	Labeling	Approval
10/03/2019	FORTEO NDA #021318	SUPPL-52	TERIPARATIDE	LILLY	Labeling	Approval
10/03/2019	ZETIA NDA #021445	SUPPL-40	EZETIMIBE	ORGANON	Labeling	Approval
10/03/2019	CHILDREN'S CLARITIN NDA #021891	SUPPL-33	LORATADINE	BAYER HEALTHCARE LLC	Labeling	Approval
10/03/2019	CLARITIN NDA #021891	SUPPL-33	LORATADINE	BAYER HEALTHCARE LLC	Labeling	Approval
10/03/2019	FOSPHENYTOIN SODIUM ANDA #078126	SUPPL-11	FOSPHENYTOIN SODIUM	APOTEX INC	Labeling	Approval
10/03/2019	FOSPHENYTOIN SODIUM ANDA #078126	SUPPL-12	FOSPHENYTOIN SODIUM	APOTEX INC	Labeling	Approval
10/03/2019	DESLORATADINE ANDA #078351	SUPPL-4	DESLORATADINE	DASH PHARMS	Labeling	Approval
10/03/2019	DESLORATADINE ANDA #078351	SUPPL-6	DESLORATADINE	DASH PHARMS	Labeling	Approval
10/03/2019	ZALEPLON ANDA #078989	SUPPL-9	ZALEPLON	UNICHEM	Labeling	Approval
10/03/2019	ZALEPLON ANDA #078989	SUPPL-10	ZALEPLON	UNICHEM	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #079183	SUPPL-7	GEMCITABINE HYDROCHLORIDE	HOSPIRA INC	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #079183	SUPPL-8	GEMCITABINE HYDROCHLORIDE	HOSPIRA INC	Labeling	Approval
10/03/2019	TRIAMCINOLONE ACETONIDE ANDA #090164	SUPPL-9	TRIAMCINOLONE ACETONIDE	SANDOZ	Labeling	Approval
10/03/2019	REPAGLINIDE ANDA #090252	SUPPL-5	REPAGLINIDE	MYLAN	Labeling	Approval
10/03/2019	REPAGLINIDE ANDA #090252	SUPPL-9	REPAGLINIDE	MYLAN	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #091365	SUPPL-8	GEMCITABINE HYDROCHLORIDE	DR REDDYS LABS LTD	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #091606	SUPPL-7	LAMIVUDINE	APOTEX	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #091606	SUPPL-8	LAMIVUDINE	APOTEX	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #091606	SUPPL-9	LAMIVUDINE	APOTEX	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #091606	SUPPL-10	LAMIVUDINE	APOTEX	Labeling	Approval
10/03/2019	NAPROXEN ANDA #200429	SUPPL-8	NAPROXEN	AUROBINDO PHARMA	Labeling	Approval
10/03/2019	NAPROXEN ANDA #200429	SUPPL-11	NAPROXEN	AUROBINDO PHARMA	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #202485	SUPPL-4	GEMCITABINE HYDROCHLORIDE	JIANGSU HANSOH PHARM	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #202485	SUPPL-5	GEMCITABINE HYDROCHLORIDE	JIANGSU HANSOH PHARM	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #202485	SUPPL-8	GEMCITABINE HYDROCHLORIDE	JIANGSU HANSOH PHARM	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #202485	SUPPL-9	GEMCITABINE HYDROCHLORIDE	JIANGSU HANSOH PHARM	Labeling	Approval
10/03/2019	DAPTOMYCIN ANDA #202857	SUPPL-12	DAPTOMYCIN	HOSPIRA	Labeling	Approval
10/03/2019	DAPTOMYCIN ANDA #202857	SUPPL-16	DAPTOMYCIN	HOSPIRA	Labeling	Approval
10/03/2019	TYBOST NDA #203094	SUPPL-14	COBICISTAT	GILEAD SCIENCES INC	Efficacy	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #204520	SUPPL-3	GEMCITABINE HYDROCHLORIDE	GLAND PHARMA LTD	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #204520	SUPPL-4	GEMCITABINE HYDROCHLORIDE	GLAND PHARMA LTD	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #204520	SUPPL-6	GEMCITABINE HYDROCHLORIDE	GLAND PHARMA LTD	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #204528	SUPPL-2	LAMIVUDINE	MYLAN	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #204528	SUPPL-3	LAMIVUDINE	MYLAN	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #204528	SUPPL-4	LAMIVUDINE	MYLAN	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #204528	SUPPL-6	LAMIVUDINE	MYLAN	Labeling	Approval
10/03/2019	LAMIVUDINE ANDA #204528	SUPPL-7	LAMIVUDINE	MYLAN	Labeling	Approval
10/03/2019	DAPTOMYCIN ANDA #206005	SUPPL-6	DAPTOMYCIN	XELLIA PHARMS APS	Labeling	Approval
10/03/2019	DAPTOMYCIN ANDA #206005	SUPPL-11	DAPTOMYCIN	XELLIA PHARMS APS	Labeling	Approval
10/03/2019	DAPTOMYCIN ANDA #206005	SUPPL-14	DAPTOMYCIN	XELLIA PHARMS APS	Labeling	Approval
10/03/2019	TRIAMCINOLONE ACETONIDE ANDA #207550	SUPPL-3	TRIAMCINOLONE ACETONIDE	AMNEAL	Labeling	Approval
10/03/2019	GEMCITABINE HYDROCHLORIDE ANDA #207575	SUPPL-1	GEMCITABINE HYDROCHLORIDE	SHILPA	Labeling	Approval
10/03/2019	DESCOVY NDA #208215	SUPPL-12	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	GILEAD SCIENCES INC	Efficacy	Approval
10/03/2019	HEMADY NDA #211379	ORIG-1	DEXAMETHASONE	DEXCEL	New Combination and New Formulation or New Manufacturer	Approval
10/03/2019	FASENRA BLA #761070	SUPPL-5	BENRALIZUMAB	ASTRAZENECA AB		Approval
10/04/2019	ZOCOR NDA #019766	SUPPL-100	SIMVASTATIN	ORGANON	Labeling	Approval
10/04/2019	CYMBALTA NDA #021427	SUPPL-51	DULOXETINE HYDROCHLORIDE	LILLY	Labeling	Approval
10/04/2019	VYTORIN NDA #021687	SUPPL-62	EZETIMIBE; SIMVASTATIN	ORGANON	Labeling	Approval
10/04/2019	MEPERIDINE HYDROCHLORIDE ANDA #040110	SUPPL-7	MEPERIDINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/04/2019	MEPERIDINE HYDROCHLORIDE ANDA #088744	SUPPL-28	MEPERIDINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/04/2019	TACROLIMUS ANDA #090509	SUPPL-16	TACROLIMUS	DR REDDYS LABS LTD	Labeling	Approval
10/04/2019	TACROLIMUS ANDA #090509	SUPPL-17	TACROLIMUS	DR REDDYS LABS LTD	Labeling	Approval
10/04/2019	TACROLIMUS ANDA #090509	SUPPL-19	TACROLIMUS	DR REDDYS LABS LTD	Labeling	Approval
10/04/2019	GUANFACINE HYDROCHLORIDE ANDA #200881	SUPPL-8	GUANFACINE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/04/2019	GUANFACINE HYDROCHLORIDE ANDA #200881	SUPPL-9	GUANFACINE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/04/2019	KYPROLIS NDA #202714	SUPPL-27	CARFILZOMIB	ONYX PHARMS AMGEN	Labeling	Approval
10/04/2019	RAVICTI NDA #203284	SUPPL-11	GLYCEROL PHENYLBUTYRATE	HORIZON THERAP US	Efficacy	Approval
10/04/2019	ITRACONAZOLE ANDA #204672	SUPPL-1	ITRACONAZOLE	ZYDUS PHARMS	Labeling	Approval
10/04/2019	ITRACONAZOLE ANDA #204672	SUPPL-2	ITRACONAZOLE	ZYDUS PHARMS	Labeling	Approval
10/04/2019	ITRACONAZOLE ANDA #204672	SUPPL-3	ITRACONAZOLE	ZYDUS PHARMS	Labeling	Approval
10/04/2019	RASAGILINE MESYLATE ANDA #206153	ORIG-1	RASAGILINE MESYLATE	INDOCO		Approval
10/04/2019	ITRACONAZOLE ANDA #206741	SUPPL-1	ITRACONAZOLE	ALEMBIC	Labeling	Approval
10/04/2019	ITRACONAZOLE ANDA #206741	SUPPL-2	ITRACONAZOLE	ALEMBIC	Labeling	Approval
10/04/2019	ITRACONAZOLE ANDA #206741	SUPPL-3	ITRACONAZOLE	ALEMBIC	Labeling	Approval
10/04/2019	ITRACONAZOLE ANDA #206741	SUPPL-4	ITRACONAZOLE	ALEMBIC	Labeling	Approval
10/04/2019	BORTEZOMIB NDA #206927	ORIG-1	BORTEZOMIB	DR REDDYS	Type 5 - New Formulation or New Manufacturer	Approval
10/04/2019	TRIPTODUR KIT NDA #208956	SUPPL-2	TRIPTORELIN PAMOATE	AZURITY	Labeling	Approval
10/04/2019	OXYCODONE AND ACETAMINOPHEN ANDA #209385	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NOSTRUM LABS INC	Labeling	Approval
10/04/2019	GEMCITABINE HYDROCHLORIDE ANDA #210991	ORIG-1	GEMCITABINE HYDROCHLORIDE	SHILPA		Approval
10/04/2019	QUZYTTIR NDA #211415	ORIG-1	CETIRIZINE HYDROCHLORIDE	JDP	Type 3 - New Dosage Form	Approval
10/04/2019	AKLIEF NDA #211527	ORIG-1	TRIFAROTENE	GALDERMA LABS LP	Type 1 - New Molecular Entity	Approval
10/04/2019	METHYLPHENIDATE HYDROCHLORIDE ANDA #211779	ORIG-1	METHYLPHENIDATE HYDROCHLORIDE	ALKEM LABS LTD		Approval
10/04/2019	BONSITY NDA #211939	ORIG-1	TERIPARATIDE	ALVOGEN	Type 5 - New Formulation or New Manufacturer	Approval
10/04/2019	DIGOXIN ANDA #213000	ORIG-1	DIGOXIN	VISTAPHARM LLC		Approval
10/04/2019	AIMOVIG BLA #761077	SUPPL-3	ERENUMAB-AOOE	AMGEN INC		Approval
10/06/2019	TAFINLAR NDA #202806	SUPPL-12	DABRAFENIB MESYLATE	NOVARTIS	Efficacy	Approval
10/06/2019	MEKINIST NDA #204114	SUPPL-12	TRAMETINIB DIMETHYL SULFOXIDE	NOVARTIS	Efficacy	Approval
10/07/2019	DEMEROL NDA #005010	SUPPL-58	MEPERIDINE HYDROCHLORIDE	VALIDUS PHARMS	Labeling	Approval
10/07/2019	DOLOPHINE HYDROCHLORIDE NDA #006134	SUPPL-49	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/07/2019	PERCODAN NDA #007337	SUPPL-52	ASPIRIN; OXYCODONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
10/07/2019	PERCODAN NDA #007337	SUPPL-52	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO PHARMS	Labeling	Approval
10/07/2019	PERCODAN-DEMI NDA #007337	SUPPL-52	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO PHARMS	Labeling	Approval
10/07/2019	SYNALGOS-DC NDA #011483	SUPPL-33	ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE	SUN PHARM INDUSTRIES	Labeling	Approval
10/07/2019	OPANA NDA #011707	SUPPL-37	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
10/07/2019	MEPERGAN NDA #011730	SUPPL-32	MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/07/2019	TALWIN NDA #016194	SUPPL-81	PENTAZOCINE LACTATE	HOSPIRA	Labeling	Approval
10/07/2019	SUBLIMAZE PRESERVATIVE FREE NDA #016619	SUPPL-43	FENTANYL CITRATE	RISING	Labeling	Approval
10/07/2019	METHADONE HYDROCHLORIDE NDA #017058	SUPPL-26	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/07/2019	METHADOSE NDA #017116	SUPPL-38	METHADONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/07/2019	NUBAIN NDA #018024	SUPPL-42	NALBUPHINE HYDROCHLORIDE	PAR PHARM INC	Labeling	Approval
10/07/2019	BUPRENEX NDA #018401	SUPPL-25	BUPRENORPHINE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/07/2019	DURAMORPH PF NDA #018565	SUPPL-24	MORPHINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	INFUMORPH NDA #018565	SUPPL-24	MORPHINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	DILAUDID NDA #019034	SUPPL-35	HYDROMORPHONE HYDROCHLORIDE	FRESENIUS KABI USA	Labeling	Approval
10/07/2019	DILAUDID-HP NDA #019034	SUPPL-35	HYDROMORPHONE HYDROCHLORIDE	FRESENIUS KABI USA	Labeling	Approval
10/07/2019	SUFENTA PRESERVATIVE FREE NDA #019050	SUPPL-37	SUFENTANIL CITRATE	RISING	Labeling	Approval
10/07/2019	FENTANYL CITRATE NDA #019115	SUPPL-33	FENTANYL CITRATE	HOSPIRA	Labeling	Approval
10/07/2019	ALFENTA NDA #019353	SUPPL-23	ALFENTANIL HYDROCHLORIDE	RISING	Labeling	Approval
10/07/2019	FIORINAL W/CODEINE NDA #019429	SUPPL-43	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ALLERGAN	Labeling	Approval
10/07/2019	MS CONTIN NDA #019516	SUPPL-55	MORPHINE SULFATE	PURDUE PHARMA LP	Labeling	Approval
10/07/2019	DURAGESIC-100 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DURAGESIC-12 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DURAGESIC-25 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DURAGESIC-37 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DURAGESIC-50 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DURAGESIC-75 NDA #019813	SUPPL-79	FENTANYL	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DILAUDID NDA #019891	SUPPL-28	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
10/07/2019	DILAUDID NDA #019892	SUPPL-35	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #019916	SUPPL-19	MORPHINE SULFATE	ICU MEDICAL INC	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #019917	SUPPL-12	MORPHINE SULFATE	ICU MEDICAL INC	Labeling	Approval
10/07/2019	MORPHINE SULFATE (AUTOINJECTOR) NDA #019999	SUPPL-23	MORPHINE SULFATE	MERIDIAN MEDCL TECHN	Labeling	Approval
10/07/2019	FIORICET W/ CODEINE NDA #020232	SUPPL-44	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ACTAVIS LABS UT INC	Labeling	Approval
10/07/2019	ULTRAM NDA #020281	SUPPL-45	TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
10/07/2019	KADIAN NDA #020616	SUPPL-63	MORPHINE SULFATE	ALLERGAN	Labeling	Approval
10/07/2019	ULTIVA NDA #020630	SUPPL-20	REMIFENTANIL HYDROCHLORIDE	MYLAN INSTITUTIONAL	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #020631	SUPPL-2	MORPHINE SULFATE	SPECGX LLC	Labeling	Approval
10/07/2019	SUBUTEX NDA #020732	SUPPL-22	BUPRENORPHINE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/07/2019	SUBOXONE NDA #020733	SUPPL-26	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/07/2019	ACTIQ NDA #020747	SUPPL-49	FENTANYL CITRATE	CEPHALON	Labeling	Approval
10/07/2019	ROXICODONE NDA #021011	SUPPL-10	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/07/2019	ULTRACET NDA #021123	SUPPL-19	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
10/07/2019	DEMEROL NDA #021171	SUPPL-32	MEPERIDINE HYDROCHLORIDE	HOSPIRA	Labeling	Approval
10/07/2019	EXALGO NDA #021217	SUPPL-25	HYDROMORPHONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/07/2019	BUTRANS NDA #021306	SUPPL-35	BUPRENORPHINE	PURDUE PHARMA LP	Labeling	Approval
10/07/2019	OPANA ER NDA #021610	SUPPL-27	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
10/07/2019	OPANA NDA #021611	SUPPL-17	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
10/07/2019	METHADONE HYDROCHLORIDE NDA #021624	SUPPL-10	METHADONE HYDROCHLORIDE	MYLAN INSTITUTIONAL	Labeling	Approval
10/07/2019	FENTORA NDA #021947	SUPPL-29	FENTANYL CITRATE	CEPHALON	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #022195	SUPPL-18	MORPHINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #022207	SUPPL-9	MORPHINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	ONSOLIS NDA #022266	SUPPL-23	FENTANYL CITRATE	ADALVO	Labeling	Approval
10/07/2019	OXYCONTIN NDA #022272	SUPPL-43	OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	Labeling	Approval
10/07/2019	NUCYNTA NDA #022304	SUPPL-22	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
10/07/2019	EMBEDA NDA #022321	SUPPL-30	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	ALPHARMA PHARMS	Labeling	Approval
10/07/2019	CONZIP NDA #022370	SUPPL-18	TRAMADOL HYDROCHLORIDE	CIPHER PHARMS INC	Labeling	Approval
10/07/2019	CODEINE SULFATE NDA #022402	SUPPL-12	CODEINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	SUBOXONE NDA #022410	SUPPL-38	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/07/2019	ABSTRAL NDA #022510	SUPPL-18	FENTANYL CITRATE	SENTYNL THERAPS INC	Labeling	Approval
10/07/2019	LAZANDA NDA #022569	SUPPL-27	FENTANYL CITRATE	BTCP PHARMA	Labeling	Approval
10/07/2019	NORCO ANDA #040099	SUPPL-23	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040119	SUPPL-15	ACETAMINOPHEN; CODEINE PHOSPHATE	AKORN	Labeling	Approval
10/07/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040148	SUPPL-73	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
10/07/2019	NORCO ANDA #040148	SUPPL-73	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
10/07/2019	PERCOCET ANDA #040330	SUPPL-55	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS LLC	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040419	SUPPL-26	ACETAMINOPHEN; CODEINE PHOSPHATE	SPECGX LLC	Labeling	Approval
10/07/2019	METAXALONE ANDA #040486	SUPPL-7	METAXALONE	MOUNTAIN	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040777	SUPPL-17	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040778	SUPPL-19	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS NY	Labeling	Approval
10/07/2019	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040860	SUPPL-5	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	INGENUS PHARMS NJ	Labeling	Approval
10/07/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040894	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	Labeling	Approval
10/07/2019	BUTORPHANOL TARTRATE ANDA #075824	SUPPL-13	BUTORPHANOL TARTRATE	HIKMA	Labeling	Approval
10/07/2019	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078316	SUPPL-11	IBUPROFEN; OXYCODONE HYDROCHLORIDE	BARR LABS INC	Labeling	Approval
10/07/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #078633	SUPPL-18	BUPRENORPHINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081249	SUPPL-12	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081250	SUPPL-12	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085861	SUPPL-78	ACETAMINOPHEN; CODEINE PHOSPHATE	ACTAVIS MID ATLANTIC	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085868	SUPPL-65	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087006	SUPPL-36	ACETAMINOPHEN; CODEINE PHOSPHATE	WOCKHARDT BIO AG	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087083	SUPPL-52	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087508	SUPPL-47	ACETAMINOPHEN; CODEINE PHOSPHATE	GENUS LIFESCIENCES	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089450	SUPPL-26	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089673	SUPPL-28	ACETAMINOPHEN; CODEINE PHOSPHATE	RHODES PHARMS	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089805	SUPPL-35	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089805	SUPPL-36	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089828	SUPPL-32	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089828	SUPPL-33	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089990	SUPPL-30	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089990	SUPPL-31	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #090733	SUPPL-18	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS	Labeling	Approval
10/07/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091149	SUPPL-14	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TEVA PHARMS USA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #091238	SUPPL-17	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL MOLECULAR	Labeling	Approval
10/07/2019	HYDROMORPHONE HYDROCHLORIDE NDA #200403	SUPPL-18	HYDROMORPHONE HYDROCHLORIDE	HOSPIRA INC	Labeling	Approval
10/07/2019	NUCYNTA ER NDA #200533	SUPPL-20	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
10/07/2019	OXYCODONE HYDROCHLORIDE NDA #200534	SUPPL-9	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
10/07/2019	OXYCODONE HYDROCHLORIDE NDA #200535	SUPPL-16	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
10/07/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #201066	SUPPL-11	BUPRENORPHINE HYDROCHLORIDE	MYLAN	Labeling	Approval
10/07/2019	OXYCODONE HYDROCHLORIDE NDA #201194	SUPPL-8	OXYCODONE HYDROCHLORIDE	VISTAPHARM LLC	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #201517	SUPPL-15	MORPHINE SULFATE	CHARTWELL MOLECULAR	Labeling	Approval
10/07/2019	OPANA ER NDA #201655	SUPPL-26	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #201972	SUPPL-13	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	Labeling	Approval
10/07/2019	OXAYDO NDA #202080	SUPPL-11	OXYCODONE HYDROCHLORIDE	ZYLA	Labeling	Approval
10/07/2019	CODEINE SULFATE NDA #202245	SUPPL-8	CODEINE SULFATE	HIKMA	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #202515	SUPPL-17	MORPHINE SULFATE	HOSPIRA INC	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #202677	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ALVOGEN	Labeling	Approval
10/07/2019	SUBSYS NDA #202788	SUPPL-20	FENTANYL	BTCP PHARMA	Labeling	Approval
10/07/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #202800	SUPPL-12	ACETAMINOPHEN; CODEINE PHOSPHATE	AUROLIFE PHARMA LLC	Labeling	Approval
10/07/2019	ZOHYDRO ER NDA #202880	SUPPL-19	HYDROCODONE BITARTRATE	RECRO GAINESVILLE	Labeling	Approval
10/07/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203326	SUPPL-14	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/07/2019	NUCYNTA NDA #203794	SUPPL-8	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
10/07/2019	FETZIMA NDA #204168	SUPPL-6	LEVOMILNACIPRAN HYDROCHLORIDE	ABBVIE	Efficacy	Approval
10/07/2019	ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ANDA #204209	SUPPL-10	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	LARKEN LABS INC	Labeling	Approval
10/07/2019	MORPHINE SULFATE NDA #204223	SUPPL-15	MORPHINE SULFATE	FRESENIUS KABI USA	Labeling	Approval
10/07/2019	ZUBSOLV NDA #204242	SUPPL-17	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	OREXO US INC	Labeling	Approval
10/07/2019	PROBUPHINE NDA #204442	SUPPL-9	BUPRENORPHINE HYDROCHLORIDE	TITAN PHARMS	Labeling	Approval
10/07/2019	BUNAVAIL NDA #205637	SUPPL-20	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	BDSI	Labeling	Approval
10/07/2019	HETLIOZ NDA #205677	SUPPL-6	TASIMELTEON	VANDA PHARMS INC	Labeling	Approval
10/07/2019	PIROXICAM ANDA #206152	SUPPL-1	PIROXICAM	MICRO LABS	Labeling	Approval
10/07/2019	MORPHABOND ER NDA #206544	SUPPL-12	MORPHINE SULFATE	OHEMO LIFE	Labeling	Approval
10/07/2019	HYSINGLA ER NDA #206627	SUPPL-10	HYDROCODONE BITARTRATE	PURDUE PHARMA LP	Labeling	Approval
10/07/2019	LAMIVUDINE ANDA #206974	SUPPL-5	LAMIVUDINE	UPSHER SMITH LABS	Labeling	Approval
10/07/2019	LAMIVUDINE ANDA #206974	SUPPL-6	LAMIVUDINE	UPSHER SMITH LABS	Labeling	Approval
10/07/2019	TADALAFIL ANDA #207244	ORIG-1	TADALAFIL	MACLEODS PHARMS LTD		Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #207419	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ASCENT PHARMS INC	Labeling	Approval
10/07/2019	COLESEVELAM HYDROCHLORIDE ANDA #207765	ORIG-1	COLESEVELAM HYDROCHLORIDE	ZYDUS PHARMS		Approval
10/07/2019	BELBUCA NDA #207932	SUPPL-12	BUPRENORPHINE HYDROCHLORIDE	BDSI	Labeling	Approval
10/07/2019	CASSIPA NDA #208042	SUPPL-1	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TEVA PHARMS USA	Labeling	Approval
10/07/2019	XTAMPZA ER NDA #208090	SUPPL-12	OXYCODONE	COLLEGIUM PHARM INC	Labeling	Approval
10/07/2019	ARYMO ER NDA #208603	SUPPL-5	MORPHINE SULFATE	ZYLA	Labeling	Approval
10/07/2019	APADAZ NDA #208653	SUPPL-5	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	ZEVRA THERAP	Labeling	Approval
10/07/2019	DSUVIA NDA #209128	SUPPL-3	SUFENTANIL CITRATE	VERTICAL PHARMS	Labeling	Approval
10/07/2019	ACYCLOVIR ANDA #209366	ORIG-1	ACYCLOVIR	SQUARE PHARMS		Approval
10/07/2019	DOXYCYCLINE HYCLATE ANDA #209402	ORIG-1	DOXYCYCLINE HYCLATE	CHANGZHOU PHARM		Approval
10/07/2019	ROXYBOND NDA #209777	SUPPL-6	OXYCODONE HYDROCHLORIDE	PROTEGA PHARMS	Labeling	Approval
10/07/2019	SUBLOCADE NDA #209819	SUPPL-9	BUPRENORPHINE	INDIVIOR	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #210644	SUPPL-3	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ABHAI LLC	Labeling	Approval
10/07/2019	SUNOSI NDA #211230	SUPPL-1	SOLRIAMFETOL HYDROCHLORIDE	AXSOME MALTA	Labeling	Approval
10/07/2019	OXYCODONE AND ACETAMINOPHEN ANDA #211499	SUPPL-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ABHAI LLC	Labeling	Approval
10/07/2019	BEOVU BLA #761125	ORIG-1	brolucizumab-dbll	NOVARTIS PHARMS CORP		Approval
10/08/2019	FENTANYL CITRATE NDA #019101	SUPPL-51	FENTANYL CITRATE	HIKMA	Labeling	Approval
10/08/2019	HYCAMTIN NDA #020671	SUPPL-24	TOPOTECAN HYDROCHLORIDE	SANDOZ	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040105	SUPPL-34	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS	Labeling	Approval
10/08/2019	MEPERIDINE HYDROCHLORIDE ANDA #040110	SUPPL-8	MEPERIDINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040171	SUPPL-35	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
10/08/2019	OXYCODONE AND ASPIRIN ANDA #040255	SUPPL-29	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ANI PHARMS	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040535	SUPPL-34	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040608	SUPPL-16	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MIKART	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040680	SUPPL-13	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/08/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040779	SUPPL-21	ACETAMINOPHEN; CODEINE PHOSPHATE	AMNEAL PHARMS NY	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040800	SUPPL-7	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/08/2019	BUTORPHANOL TARTRATE ANDA #075759	SUPPL-31	BUTORPHANOL TARTRATE	RISING	Labeling	Approval
10/08/2019	MOMETASONE FUROATE ANDA #077180	SUPPL-9	MOMETASONE FUROATE	PADAGIS ISRAEL	Labeling	Approval
10/08/2019	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078769	SUPPL-25	IBUPROFEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/08/2019	PERCOCET ANDA #085106	SUPPL-29	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS LLC	Labeling	Approval
10/08/2019	ROXICET ANDA #087003	SUPPL-43	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/08/2019	MEPERIDINE HYDROCHLORIDE ANDA #088744	SUPPL-29	MEPERIDINE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/08/2019	ROXICET ANDA #089351	SUPPL-31	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/08/2019	OXYCODONE AND ASPIRIN ANDA #090084	SUPPL-8	ASPIRIN; OXYCODONE HYDROCHLORIDE	ACTAVIS LABS FL INC	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #090177	SUPPL-17	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	Labeling	Approval
10/08/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #090360	SUPPL-17	BUPRENORPHINE HYDROCHLORIDE	BARR	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #090734	SUPPL-24	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS	Labeling	Approval
10/08/2019	OXYCODONE AND ASPIRIN ANDA #091670	SUPPL-5	ASPIRIN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #201278	SUPPL-10	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #201447	SUPPL-16	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #202142	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MIKART	Labeling	Approval
10/08/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #203136	SUPPL-21	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	AMNEAL PHARMS	Labeling	Approval
10/08/2019	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ANDA #203573	SUPPL-8	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS	Labeling	Approval
10/08/2019	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ANDA #203573	SUPPL-9	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	VINTAGE PHARMS	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #203864	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	EPIC PHARMA LLC	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #204407	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	Labeling	Approval
10/08/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205022	SUPPL-6	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
10/08/2019	PREGABALIN ANDA #206912	ORIG-1	PREGABALIN	HETERO LABS LTD III		Approval
10/08/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207000	SUPPL-4	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #207333	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #207574	SUPPL-7	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	CEROVENE INC	Labeling	Approval
10/08/2019	OLUMIANT NDA #207924	SUPPL-1	BARICITINIB	ELI LILLY AND CO	Efficacy	Approval
10/08/2019	BENDEKA NDA #208194	SUPPL-19	BENDAMUSTINE HYDROCHLORIDE	EAGLE PHARMS	Labeling	Approval
10/08/2019	OXYCODONE AND ACETAMINOPHEN ANDA #209385	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NOSTRUM LABS INC	Labeling	Approval
10/08/2019	SCENESSE NDA #210797	ORIG-1	AFAMELANOTIDE	CLIVUNEL INC	Type 1 - New Molecular Entity	Approval
10/09/2019	LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER NDA #016679	SUPPL-114	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	LACTATED RINGER'S IN PLASTIC CONTAINER NDA #016682	SUPPL-117	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	HALCION NDA #017892	SUPPL-50	TRIAZOLAM	PFIZER	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019367	SUPPL-36	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	BAXTER HLTHCARE	Labeling	Approval
10/09/2019	ADDYI NDA #022526	SUPPL-8	FLIBANSERIN	SPROUT PHARMS	Labeling	Approval
10/09/2019	ADDYI NDA #022526	SUPPL-9	FLIBANSERIN	SPROUT PHARMS	REMS	Approval
10/09/2019	OXYCODONE AND ASPIRIN ANDA #040260	SUPPL-17	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	Labeling	Approval
10/09/2019	NALBUPHINE HYDROCHLORIDE ANDA #074471	SUPPL-4	NALBUPHINE HYDROCHLORIDE	DR REDDYS	Labeling	Approval
10/09/2019	BUTORPHANOL TARTRATE ANDA #075499	SUPPL-26	BUTORPHANOL TARTRATE	APOTEX	Labeling	Approval
10/09/2019	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075523	SUPPL-5	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	SUN PHARM INDS LTD	Labeling	Approval
10/09/2019	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075735	SUPPL-15	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	LUPIN	Labeling	Approval
10/09/2019	HALOPERIDOL ANDA #075858	SUPPL-22	HALOPERIDOL LACTATE	HIKMA	Labeling	Approval
10/09/2019	ITRACONAZOLE ANDA #076104	SUPPL-19	ITRACONAZOLE	SANDOZ	Labeling	Approval
10/09/2019	ITRACONAZOLE ANDA #076104	SUPPL-20	ITRACONAZOLE	SANDOZ	Labeling	Approval
10/09/2019	ITRACONAZOLE ANDA #076104	SUPPL-21	ITRACONAZOLE	SANDOZ	Labeling	Approval
10/09/2019	ITRACONAZOLE ANDA #076104	SUPPL-22	ITRACONAZOLE	SANDOZ	Labeling	Approval
10/09/2019	HALOPERIDOL ANDA #078347	SUPPL-13	HALOPERIDOL LACTATE	MYLAN LABS LTD	Labeling	Approval
10/09/2019	TRAMADOL HYDROCHLORIDE ANDA #078783	SUPPL-10	TRAMADOL HYDROCHLORIDE	STRIDES PHARMA	Labeling	Approval
10/09/2019	CELECOXIB ANDA #078857	SUPPL-7	CELECOXIB	MYLAN	Labeling	Approval
10/09/2019	METHADONE HYDROCHLORIDE ANDA #087393	SUPPL-48	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/09/2019	OXYCODONE AND ASPIRIN ANDA #087794	SUPPL-29	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	Labeling	Approval
10/09/2019	METHADONE HYDROCHLORIDE ANDA #087997	SUPPL-40	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/09/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #088629	SUPPL-70	ACETAMINOPHEN; CODEINE PHOSPHATE	NOSTRUM LABS INC	Labeling	Approval
10/09/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089997	SUPPL-23	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
10/09/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089998	SUPPL-23	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
10/09/2019	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089999	SUPPL-22	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #090279	SUPPL-10	BUPRENORPHINE HYDROCHLORIDE	RUBICON	Labeling	Approval
10/09/2019	OXYCODONE AND ACETAMINOPHEN ANDA #090535	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SUN PHARM INDS INC	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #090622	SUPPL-30	BUPRENORPHINE HYDROCHLORIDE	ETHYPHARM	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #090819	SUPPL-16	BUPRENORPHINE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/09/2019	ANASTROZOLE ANDA #091164	SUPPL-2	ANASTROZOLE	CIPLA	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422	SUPPL-29	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/09/2019	GRANIX BLA #125294	SUPPL-48	TBO-FILGRASTIM	SICOR BIOTECH		Approval
10/09/2019	TRAMADOL HYDROCHLORIDE ANDA #200503	SUPPL-9	TRAMADOL HYDROCHLORIDE	LUPIN LTD	Labeling	Approval
10/09/2019	CELECOXIB ANDA #200562	SUPPL-4	CELECOXIB	WATSON LABS INC	Labeling	Approval
10/09/2019	CELECOXIB ANDA #200562	SUPPL-5	CELECOXIB	WATSON LABS INC	Labeling	Approval
10/09/2019	OXYMORPHONE HYDROCHLORIDE ANDA #200822	SUPPL-14	OXYMORPHONE HYDROCHLORIDE	HIKMA	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #201633	SUPPL-9	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	SUN PHARM	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE ANDA #201760	SUPPL-12	BUPRENORPHINE HYDROCHLORIDE	SUN PHARM	Labeling	Approval
10/09/2019	CELECOXIB ANDA #202240	SUPPL-4	CELECOXIB	LUPIN LTD	Labeling	Approval
10/09/2019	CELECOXIB ANDA #202240	SUPPL-7	CELECOXIB	LUPIN LTD	Manufacturing (CMC)	Approval
10/09/2019	CELECOXIB ANDA #202240	SUPPL-8	CELECOXIB	LUPIN LTD	Labeling	Approval
10/09/2019	DECITABINE ANDA #203131	SUPPL-6	DECITABINE	DR REDDYS	Labeling	Approval
10/09/2019	BOSULIF NDA #203341	SUPPL-17	BOSUTINIB MONOHYDRATE	PF PRISM CV	Labeling	Approval
10/09/2019	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #204431	SUPPL-17	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	ETHYPHARM USA CORP	Labeling	Approval
10/09/2019	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ANDA #207310	SUPPL-5	SODIUM CHLORIDE	FRESENIUS KABI USA	Manufacturing (CMC)	Approval
10/09/2019	OXYCODONE AND ACETAMINOPHEN ANDA #207510	SUPPL-3	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WES PHARMA INC	Labeling	Approval
10/09/2019	OXYCODONE AND ACETAMINOPHEN ANDA #207510	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WES PHARMA INC	Labeling	Approval
10/09/2019	CAPECITABINE ANDA #207652	SUPPL-3	CAPECITABINE	ALKEM LABS LTD	Labeling	Approval
10/09/2019	DAUNORUBICIN HYDROCHLORIDE ANDA #208759	SUPPL-1	DAUNORUBICIN HYDROCHLORIDE	HISUN PHARM HANGZHOU	Manufacturing (CMC)	Approval
10/09/2019	DOXYCYCLINE HYCLATE ANDA #211343	ORIG-1	DOXYCYCLINE HYCLATE	CHANGZHOU PHARM		Approval
10/09/2019	SUCCINYLCHOLINE CHLORIDE ANDA #212638	ORIG-1	SUCCINYLCHOLINE CHLORIDE	BRECKENRIDGE		Approval
10/10/2019	ENTEREG NDA #021775	SUPPL-16	ALVIMOPAN	CUBIST PHARMS	Labeling	Approval
10/10/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040736	SUPPL-21	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
10/10/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040746	SUPPL-23	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
10/10/2019	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #074736	SUPPL-35	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
10/10/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076642	SUPPL-28	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	Labeling	Approval
10/10/2019	REPREXAIN ANDA #076642	SUPPL-28	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	Labeling	Approval
10/10/2019	OXYMORPHONE HYDROCHLORIDE ANDA #079046	SUPPL-30	OXYMORPHONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/10/2019	OXYMORPHONE HYDROCHLORIDE ANDA #079046	SUPPL-31	OXYMORPHONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/10/2019	FLUORODOPA F18 NDA #200655	ORIG-1	FLUORODOPA F-18	FEINSTEIN	Type 1 - New Molecular Entity	Approval
10/10/2019	NALBUPHINE HYDROCHLORIDE ANDA #206506	SUPPL-1	NALBUPHINE HYDROCHLORIDE	RISING	Labeling	Approval
10/10/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206869	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
10/10/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207137	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS	Labeling	Approval
10/10/2019	CAPECITABINE ANDA #207456	SUPPL-1	CAPECITABINE	SHILPA	Labeling	Approval
10/10/2019	CAPECITABINE ANDA #207456	SUPPL-2	CAPECITABINE	SHILPA	Labeling	Approval
10/10/2019	NALBUPHINE HYDROCHLORIDE ANDA #207595	SUPPL-1	NALBUPHINE HYDROCHLORIDE	RISING	Labeling	Approval
10/10/2019	DOXYCYCLINE HYCLATE ANDA #209372	SUPPL-1	DOXYCYCLINE HYCLATE	AMNEAL PHARMS CO	Labeling	Approval
10/10/2019	CASPOFUNGIN ACETATE ANDA #209489	SUPPL-1	CASPOFUNGIN ACETATE	CIPLA	Labeling	Approval
10/10/2019	PIFELTRO NDA #210806	SUPPL-3	DORAVIRINE	MSD MERCK CO	Efficacy	Approval
10/10/2019	DELSTRIGO NDA #210807	SUPPL-3	DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	MSD MERCK CO	Efficacy	Approval
10/11/2019	FERAHEME NDA #022180	SUPPL-23	FERUMOXYTOL	COVIS	Labeling	Approval
10/11/2019	DOCETAXEL NDA #022234	SUPPL-12	DOCETAXEL	HOSPIRA INC	Labeling	Approval
10/11/2019	DOCETAXEL NDA #022234	SUPPL-13	DOCETAXEL	HOSPIRA INC	Labeling	Approval
10/11/2019	DOCETAXEL NDA #022234	SUPPL-15	DOCETAXEL	HOSPIRA INC	Labeling	Approval
10/11/2019	XARELTO NDA #022406	SUPPL-33	RIVAROXABAN	JANSSEN PHARMS	Efficacy	Approval
10/11/2019	MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #040163	SUPPL-4	MEPERIDINE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/11/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040203	SUPPL-11	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040248	SUPPL-7	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040355	SUPPL-39	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040355	SUPPL-41	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040400	SUPPL-30	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
10/11/2019	ANEXSIA 7.5/325 ANDA #040405	SUPPL-30	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
10/11/2019	ANEXSIA 5/325 ANDA #040409	SUPPL-30	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
10/11/2019	OXYCODONE AND ACETAMINOPHEN ANDA #040545	SUPPL-17	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040655	SUPPL-29	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040655	SUPPL-31	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040656	SUPPL-29	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040656	SUPPL-31	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040658	SUPPL-15	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040826	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS LTD	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040834	SUPPL-17	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040838	SUPPL-15	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040881	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	Labeling	Approval
10/11/2019	ERYTHROMYCIN ANDA #061621	SUPPL-43	ERYTHROMYCIN	AZURITY	Labeling	Approval
10/11/2019	LEVORPHANOL TARTRATE ANDA #074278	SUPPL-14	LEVORPHANOL TARTRATE	HIKMA	Labeling	Approval
10/11/2019	BUTORPHANOL TARTRATE PRESERVATIVE FREE ANDA #074626	SUPPL-30	BUTORPHANOL TARTRATE	HOSPIRA	Labeling	Approval
10/11/2019	BUTORPHANOL TARTRATE PRESERVATIVE FREE ANDA #075045	SUPPL-15	BUTORPHANOL TARTRATE	HIKMA	Labeling	Approval
10/11/2019	BUTORPHANOL TARTRATE ANDA #075046	SUPPL-13	BUTORPHANOL TARTRATE	HIKMA	Labeling	Approval
10/11/2019	BUTORPHANOL TARTRATE PRESERVATIVE FREE ANDA #075695	SUPPL-23	BUTORPHANOL TARTRATE	BAXTER HLTHCARE CORP	Labeling	Approval
10/11/2019	BUTORPHANOL TARTRATE ANDA #075697	SUPPL-15	BUTORPHANOL TARTRATE	BAXTER HLTHCARE CORP	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076604	SUPPL-23	HYDROCODONE BITARTRATE; IBUPROFEN	ACTAVIS LABS FL INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077454	SUPPL-5	HYDROCODONE BITARTRATE; IBUPROFEN	ANI PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE ANDA #077723	SUPPL-27	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723	SUPPL-27	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
10/11/2019	KETOROLAC TROMETHAMINE ANDA #078737	SUPPL-3	KETOROLAC TROMETHAMINE	SUN PHARM	Labeling	Approval
10/11/2019	MORPHINE SULFATE ANDA #079040	SUPPL-21	MORPHINE SULFATE	ACTAVIS ELIZABETH	Labeling	Approval
10/11/2019	OXYMORPHONE HYDROCHLORIDE ANDA #079087	SUPPL-38	OXYMORPHONE HYDROCHLORIDE	IMPAX LABS	Labeling	Approval
10/11/2019	MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #081002	SUPPL-10	MEPERIDINE HYDROCHLORIDE	WEST-WARD PHARMS INT	Labeling	Approval
10/11/2019	MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #081309	SUPPL-10	MEPERIDINE HYDROCHLORIDE	INTL MEDICATION	Labeling	Approval
10/11/2019	OXYCET ANDA #087463	SUPPL-45	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090118	SUPPL-32	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090415	SUPPL-18	ACETAMINOPHEN; HYDROCODONE BITARTRATE	VINTAGE PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090415	SUPPL-20	ACETAMINOPHEN; HYDROCODONE BITARTRATE	VINTAGE PHARMS	Labeling	Approval
10/11/2019	POLYETHYLENE GLYCOL 3350 ANDA #090685	SUPPL-9	POLYETHYLENE GLYCOL 3350	PERRIGO R AND D	Manufacturing (CMC)	Approval
10/11/2019	METHADONE HYDROCHLORIDE ANDA #090707	SUPPL-23	METHADONE HYDROCHLORIDE	VISTAPHARM LLC	Labeling	Approval
10/11/2019	TRAMADOL HYDROCHLORIDE ANDA #091607	SUPPL-19	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
10/11/2019	TRAMADOL HYDROCHLORIDE ANDA #091609	SUPPL-9	TRAMADOL HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #091633	SUPPL-11	HYDROCODONE BITARTRATE; IBUPROFEN	SUN PHARM INDS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #200343	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #200463	SUPPL-5	ITRACONAZOLE	MYLAN PHARMS INC	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #200463	SUPPL-6	ITRACONAZOLE	MYLAN PHARMS INC	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #200463	SUPPL-7	ITRACONAZOLE	MYLAN PHARMS INC	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #200463	SUPPL-8	ITRACONAZOLE	MYLAN PHARMS INC	Labeling	Approval
10/11/2019	TRAMADOL HYDROCHLORIDE ANDA #200491	SUPPL-12	TRAMADOL HYDROCHLORIDE	ANCHEN PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #201013	SUPPL-13	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC	Labeling	Approval
10/11/2019	GILOTRIF NDA #201292	SUPPL-15	AFATINIB DIMALEATE	BOEHRINGER INGELHEIM	Labeling	Approval
10/11/2019	TRAMADOL HYDROCHLORIDE ANDA #201384	SUPPL-17	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202214	SUPPL-10	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TRIS PHARMA INC	Labeling	Approval
10/11/2019	GLIPIZIDE ANDA #202298	SUPPL-4	GLIPIZIDE	MYLAN	Labeling	Approval
10/11/2019	GLIPIZIDE ANDA #202298	SUPPL-6	GLIPIZIDE	MYLAN	Labeling	Approval
10/11/2019	XARELTO NDA #202439	SUPPL-33	RIVAROXABAN	JANSSEN PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202935	SUPPL-8	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	OXYMORPHONE HYDROCHLORIDE ANDA #202946	SUPPL-10	OXYMORPHONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202991	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	RHODES PHARMS	Labeling	Approval
10/11/2019	GLIPIZIDE ANDA #203499	SUPPL-1	GLIPIZIDE	ZYDUS PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #203863	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	EPIC PHARMA LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #204575	SUPPL-5	HYDROCODONE BITARTRATE; IBUPROFEN	AUROLIFE PHARMA LLC	Labeling	Approval
10/11/2019	TREZIX ANDA #204785	SUPPL-9	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	KEY THERAP	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #205001	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #205080	SUPPL-1	ITRACONAZOLE	AMNEAL PHARMS	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #205080	SUPPL-2	ITRACONAZOLE	AMNEAL PHARMS	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #205080	SUPPL-3	ITRACONAZOLE	AMNEAL PHARMS	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #205080	SUPPL-4	ITRACONAZOLE	AMNEAL PHARMS	Labeling	Approval
10/11/2019	TRAMADOL HYDROCHLORIDE ANDA #205257	SUPPL-8	TRAMADOL HYDROCHLORIDE	MYLAN	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206142	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206245	SUPPL-8	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206470	SUPPL-7	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ACTAVIS LABS FL INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206484	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	UPSHER SMITH LABS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206718	SUPPL-7	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
10/11/2019	GLIPIZIDE ANDA #206928	SUPPL-2	GLIPIZIDE	AUROBINDO PHARMA	Labeling	Approval
10/11/2019	GLIPIZIDE ANDA #206928	SUPPL-4	GLIPIZIDE	AUROBINDO PHARMA	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207171	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207172	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207509	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207509	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207709	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207808	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	RHODES PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #208540	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ALVOGEN	Labeling	Approval
10/11/2019	LYNPARZA NDA #208558	SUPPL-12	OLAPARIB	ASTRAZENECA	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #208591	SUPPL-2	ITRACONAZOLE	ALKEM LABS LTD	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #208591	SUPPL-3	ITRACONAZOLE	ALKEM LABS LTD	Labeling	Approval
10/11/2019	ITRACONAZOLE ANDA #208591	SUPPL-4	ITRACONAZOLE	ALKEM LABS LTD	Labeling	Approval
10/11/2019	BETAMETHASONE DIPROPIONATE ANDA #208849	ORIG-1	BETAMETHASONE DIPROPIONATE	HIKMA		Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209036	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209037	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	Labeling	Approval
10/11/2019	ATORVASTATIN CALCIUM ANDA #209288	SUPPL-1	ATORVASTATIN CALCIUM	ALKEM LABS LTD	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209924	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOSTRUM LABS INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209958	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ALVOGEN	Labeling	Approval
10/11/2019	OXYCODONE AND ACETAMINOPHEN ANDA #210079	SUPPL-3	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NESHER PHARMS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #210211	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #210211	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	Labeling	Approval
10/11/2019	REYVOW NDA #211280	ORIG-1	LASMIDITAN SUCCINATE	ELI LILLY AND CO	Type 1 - New Molecular Entity	Approval
10/11/2019	LEVORPHANOL TARTRATE ANDA #211484	SUPPL-1	LEVORPHANOL TARTRATE	VIRTUS	Labeling	Approval
10/11/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #211487	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ASCENT PHARMS INC	Labeling	Approval
10/11/2019	SECUADO NDA #212268	ORIG-1	ASENAPINE	HISAMITSU	Type 3 - New Dosage Form	Approval
10/13/2019	KETOROLAC TROMETHAMINE ANDA #076583	SUPPL-3	KETOROLAC TROMETHAMINE	SANDOZ	Labeling	Approval
10/15/2019	KETOROLAC TROMETHAMINE ANDA #078434	SUPPL-3	KETOROLAC TROMETHAMINE	CHARTWELL RX	Labeling	Approval
10/15/2019	ADCETRIS BLA #125388	SUPPL-100	BRENTUXIMAB VEDOTIN	SEATTLE GENETICS		Approval
10/15/2019	FEBUXOSTAT ANDA #205414	ORIG-1	FEBUXOSTAT	HIKMA		Approval
10/15/2019	NALOXONE HYDROCHLORIDE ANDA #212455	ORIG-1	NALOXONE HYDROCHLORIDE	EUGIA PHARMA		Approval
10/16/2019	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040118	SUPPL-19	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	SANDOZ	Labeling	Approval
10/16/2019	NALBUPHINE HYDROCHLORIDE ANDA #070914	SUPPL-20	NALBUPHINE HYDROCHLORIDE	HOSPIRA	Labeling	Approval
10/16/2019	NALBUPHINE HYDROCHLORIDE ANDA #070915	SUPPL-28	NALBUPHINE HYDROCHLORIDE	HOSPIRA	Labeling	Approval
10/16/2019	NALBUPHINE HYDROCHLORIDE ANDA #070916	SUPPL-19	NALBUPHINE HYDROCHLORIDE	HOSPIRA	Labeling	Approval
10/16/2019	NALBUPHINE HYDROCHLORIDE ANDA #070918	SUPPL-28	NALBUPHINE HYDROCHLORIDE	HOSPIRA	Labeling	Approval
10/16/2019	OFLOXACIN ANDA #091656	SUPPL-5	OFLOXACIN	CADILA PHARMS LTD	Labeling	Approval
10/16/2019	ATORVASTATIN CALCIUM ANDA #204991	SUPPL-2	ATORVASTATIN CALCIUM	LUPIN LTD	Labeling	Approval
10/16/2019	DAKLINZA NDA #206843	SUPPL-8	DACLATASVIR DIHYDROCHLORIDE	BRISTOL-MYERS SQUIBB	Labeling	Approval
10/16/2019	TADALAFIL ANDA #207290	ORIG-1	TADALAFIL	MACLEODS PHARMS LTD		Approval
10/16/2019	ATORVASTATIN CALCIUM ANDA #207687	SUPPL-1	ATORVASTATIN CALCIUM	ACCORD HLTHCARE	Labeling	Approval
10/16/2019	ATORVASTATIN CALCIUM ANDA #207687	SUPPL-4	ATORVASTATIN CALCIUM	ACCORD HLTHCARE	Labeling	Approval
10/16/2019	BELBUCA NDA #207932	SUPPL-10	BUPRENORPHINE HYDROCHLORIDE	BDSI	Labeling	Approval
10/16/2019	ABIRATERONE ACETATE ANDA #209227	ORIG-1	ABIRATERONE ACETATE	GLENMARK PHARMS		Approval
10/16/2019	XOFLUZA NDA #210854	SUPPL-1	BALOXAVIR MARBOXIL	GENENTECH INC	Efficacy	Approval
10/16/2019	ESOMEPRAZOLE MAGNESIUM ANDA #212376	ORIG-1	ESOMEPRAZOLE MAGNESIUM	MYLAN		Approval
10/16/2019	NEOSTIGMINE METHYLSULFATE ANDA #212968	ORIG-1	NEOSTIGMINE METHYLSULFATE	GLAND PHARMA LTD		Approval
10/17/2019	BENICAR NDA #021286	SUPPL-40	OLMESARTAN MEDOXOMIL	COSETTE	Labeling	Approval
10/17/2019	GEMCITABINE HYDROCHLORIDE ANDA #078759	SUPPL-6	GEMCITABINE HYDROCHLORIDE	TEYRO LABS	Labeling	Approval
10/17/2019	ZALEPLON ANDA #078829	SUPPL-10	ZALEPLON	AUROBINDO PHARMA	Labeling	Approval
10/17/2019	ZALEPLON ANDA #078829	SUPPL-12	ZALEPLON	AUROBINDO PHARMA	Labeling	Approval
10/17/2019	METOPROLOL SUCCINATE ANDA #090615	SUPPL-2	METOPROLOL SUCCINATE	WOCKHARDT	Labeling	Approval
10/17/2019	REPAGLINIDE ANDA #091517	SUPPL-1	REPAGLINIDE	KENTON	Labeling	Approval
10/17/2019	REPAGLINIDE ANDA #091517	SUPPL-2	REPAGLINIDE	KENTON	Labeling	Approval
10/17/2019	GEMCITABINE HYDROCHLORIDE ANDA #091594	SUPPL-12	GEMCITABINE HYDROCHLORIDE	ACCORD HLTHCARE	Labeling	Approval
10/17/2019	GEMCITABINE HYDROCHLORIDE ANDA #091594	SUPPL-13	GEMCITABINE HYDROCHLORIDE	ACCORD HLTHCARE	Labeling	Approval
10/17/2019	GEMCITABINE HYDROCHLORIDE ANDA #091594	SUPPL-14	GEMCITABINE HYDROCHLORIDE	ACCORD HLTHCARE	Labeling	Approval
10/17/2019	NPLATE BLA #125268	SUPPL-164	ROMIPLOSTIM	AMGEN		Approval
10/17/2019	PARICALCITOL NDA #207174	SUPPL-6	PARICALCITOL	ACCORD HLTHCARE	Labeling	Approval
10/17/2019	PIROXICAM ANDA #208340	SUPPL-3	PIROXICAM	UNICHEM	Labeling	Approval
10/17/2019	PIROXICAM ANDA #209256	SUPPL-4	PIROXICAM	HIKMA	Labeling	Approval
10/17/2019	ACETAZOLAMIDE ANDA #210588	ORIG-1	ACETAZOLAMIDE	NOVITIUM PHARMA		Approval
10/17/2019	TAMSULOSIN HYDROCHLORIDE ANDA #211885	ORIG-1	TAMSULOSIN HYDROCHLORIDE	CHARTWELL RX		Approval
10/17/2019	LIDOCAINE ANDA #212486	ORIG-1	LIDOCAINE	AILEX PHARMS LLC		Approval
10/17/2019	UDENYCA BLA #761039	SUPPL-4	PEGFILGRASTIM-CBQV	COHERUS BIOSCIENCES INC		Approval
10/18/2019	LIVALO NDA #022363	SUPPL-17	PITAVASTATIN CALCIUM	KOWA CO	Labeling	Approval
10/18/2019	KETOROLAC TROMETHAMINE ANDA #074955	SUPPL-4	KETOROLAC TROMETHAMINE	WATSON LABS	Labeling	Approval
10/18/2019	DESLORATADINE ANDA #078357	SUPPL-5	DESLORATADINE	ORBION PHARMS	Labeling	Approval
10/18/2019	KETOROLAC TROMETHAMINE ANDA #078721	SUPPL-3	KETOROLAC TROMETHAMINE	SANDOZ	Labeling	Approval
10/18/2019	BOTOX BLA #103000	SUPPL-5310	OnabotulinumtoxinA	ALLERGAN		Approval
10/18/2019	BOTOX COSMETIC BLA #103000	SUPPL-5310	OnabotulinumtoxinA	ALLERGAN		Approval
10/18/2019	STELARA BLA #125261	SUPPL-152	USTEKINUMAB	CENTOCOR ORTHO BIOTECH INC		Approval
10/18/2019	FARXIGA NDA #202293	SUPPL-18	DAPAGLIFLOZIN	ASTRAZENECA AB	Efficacy	Approval
10/18/2019	KETOROLAC TROMETHAMINE ANDA #203376	SUPPL-1	KETOROLAC TROMETHAMINE	EPIC PHARMA LLC	Labeling	Approval
10/18/2019	ORENITRAM NDA #203496	SUPPL-11	TREPROSTINIL DIOLAMINE	UNITED THERAP	Efficacy	Approval
10/18/2019	VAZCULEP NDA #204300	SUPPL-8	PHENYLEPHRINE HYDROCHLORIDE	EXELA PHARMA	Labeling	Approval
10/18/2019	XIGDUO XR NDA #205649	SUPPL-11	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	ASTRAZENECA AB	Efficacy	Approval
10/18/2019	TIGECYCLINE ANDA #205722	ORIG-1	TIGECYCLINE	XELLIA PHARMS APS		Approval
10/18/2019	ATORVASTATIN CALCIUM ANDA #206536	SUPPL-3	ATORVASTATIN CALCIUM	ZYDUS PHARMS	Labeling	Approval
10/18/2019	DIVALPROEX SODIUM ANDA #209286	ORIG-1	DIVALPROEX SODIUM	LUPIN LTD		Approval
10/18/2019	CLENPIQ NDA #209589	SUPPL-6	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	FERRING PHARMS INC	Efficacy	Approval
10/18/2019	FEXOFENADINE HYDROCHLORIDE ALLERGY ANDA #211075	ORIG-1	FEXOFENADINE HYDROCHLORIDE	GRANULES		Approval
10/18/2019	SIROLIMUS ANDA #211212	ORIG-1	SIROLIMUS	AMNEAL		Approval
10/18/2019	ACETAZOLAMIDE ANDA #211556	ORIG-1	ACETAZOLAMIDE	EYWA PHARMA		Approval
10/18/2019	AMZEEQ NDA #212379	ORIG-1	MINOCYCLINE HYDROCHLORIDE	JOURNEY	Type 3 - New Dosage Form	Approval
10/18/2019	ERELZI BLA #761042	SUPPL-10	ETANERCEPT-SZZS	SANDOZ		Approval
10/18/2019	STELARA BLA #761044	SUPPL-3	USTEKINUMAB	JANSSEN BIOTECH		Approval
10/18/2019	ULTOMIRIS BLA #761108	SUPPL-1	RAVULIZUMAB-CWVZ	ALEXION PHARM		Approval
10/21/2019	ELELYSO BLA #022458	SUPPL-23	TALIGLUCERASE ALFA	PFIZER		Approval
10/21/2019	GEMFIBROZIL ANDA #074270	SUPPL-17	GEMFIBROZIL	CHARTWELL MOLECULES	Labeling	Approval
10/21/2019	ZALEPLON ANDA #077237	SUPPL-3	ZALEPLON	HIKMA	Labeling	Approval
10/21/2019	ZALEPLON ANDA #077237	SUPPL-4	ZALEPLON	HIKMA	Labeling	Approval
10/21/2019	FOSPHENYTOIN SODIUM ANDA #078476	SUPPL-8	FOSPHENYTOIN SODIUM	AMNEAL	Labeling	Approval
10/21/2019	FOSPHENYTOIN SODIUM ANDA #078476	SUPPL-9	FOSPHENYTOIN SODIUM	AMNEAL	Labeling	Approval
10/21/2019	FOSPHENYTOIN SODIUM ANDA #078476	SUPPL-10	FOSPHENYTOIN SODIUM	AMNEAL	Labeling	Approval
10/21/2019	FOSPHENYTOIN SODIUM ANDA #078476	SUPPL-12	FOSPHENYTOIN SODIUM	AMNEAL	Labeling	Approval
10/21/2019	ZALEPLON ANDA #090374	SUPPL-2	ZALEPLON	ORBION PHARMS	Labeling	Approval
10/21/2019	ZALEPLON ANDA #090374	SUPPL-3	ZALEPLON	ORBION PHARMS	Labeling	Approval
10/21/2019	CLOPIDOGREL BISULFATE ANDA #090494	SUPPL-17	CLOPIDOGREL BISULFATE	SUN PHARM	Labeling	Approval
10/21/2019	METOPROLOL TARTRATE ANDA #091307	SUPPL-2	METOPROLOL TARTRATE	LUITPOLD	Labeling	Approval
10/21/2019	ZOLMITRIPTAN ANDA #203726	ORIG-1	ZOLMITRIPTAN	ORBION PHARMS		Approval
10/21/2019	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-6	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
10/21/2019	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-7	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
10/21/2019	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-8	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
10/21/2019	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-13	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
10/21/2019	ATORVASTATIN CALCIUM ANDA #205519	SUPPL-18	ATORVASTATIN CALCIUM	SCIEGEN PHARMS INC	Labeling	Approval
10/21/2019	FIASP BLA #208751	SUPPL-8	INSULIN ASPART	NOVO		Approval
10/21/2019	FIASP BLA #208751	SUPPL-13	INSULIN ASPART	NOVO		Approval
10/21/2019	FIASP FLEXTOUCH BLA #208751	SUPPL-8	INSULIN ASPART	NOVO		Approval
10/21/2019	FIASP FLEXTOUCH BLA #208751	SUPPL-13	INSULIN ASPART	NOVO		Approval
10/21/2019	FIASP PENFILL BLA #208751	SUPPL-8	INSULIN ASPART	NOVO		Approval
10/21/2019	FIASP PENFILL BLA #208751	SUPPL-13	INSULIN ASPART	NOVO		Approval
10/21/2019	CINVANTI NDA #209296	SUPPL-4	APREPITANT	HERON THERAPS INC	Efficacy	Approval
10/21/2019	ITRACONAZOLE ANDA #209460	SUPPL-2	ITRACONAZOLE	TORRENT	Labeling	Approval
10/21/2019	CLOVIQUE ANDA #209731	ORIG-1	TRIENTINE HYDROCHLORIDE	CHARTWELL RX		Approval
10/21/2019	GUAIFENESIN ANDA #210453	ORIG-1	GUAIFENESIN	AUROBINDO PHARMA		Approval
10/21/2019	CARBIDOPA ANDA #211055	ORIG-1	CARBIDOPA	AUROBINDO PHARMA		Approval
10/21/2019	LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #211983	SUPPL-1	LEVOCETIRIZINE DIHYDROCHLORIDE	PERRIGO R AND D	Manufacturing (CMC)	Approval
10/21/2019	CLOMIPRAMINE HYDROCHLORIDE ANDA #212218	ORIG-1	CLOMIPRAMINE HYDROCHLORIDE	JUBILANT CADISTA		Approval
10/21/2019	TRIKAFTA (COPACKAGED) NDA #212273	ORIG-1	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR	VERTEX PHARMS INC	Type 1 - New Molecular Entity and Type 4 - New Combination	Approval
10/21/2019	CLOBETASOL PROPIONATE ANDA #212881	ORIG-1	CLOBETASOL PROPIONATE	ALEMBIC		Approval
10/21/2019	BIORPHEN NDA #212909	ORIG-1	PHENYLEPHRINE HYDROCHLORIDE	DR REDDYS LABS SA	Type 5 - New Formulation or New Manufacturer	Approval
10/22/2019	ZYPREXA NDA #020592	SUPPL-72	OLANZAPINE	CHEPLAPHARM	Labeling	Approval
10/22/2019	ZYPREXA ZYDIS NDA #021086	SUPPL-47	OLANZAPINE	CHEPLAPHARM	Labeling	Approval
10/22/2019	ZYPREXA NDA #021253	SUPPL-60	OLANZAPINE	CHEPLAPHARM	Labeling	Approval
10/22/2019	DAYTRANA NDA #021514	SUPPL-30	METHYLPHENIDATE	NOVEN PHARMS INC	Labeling	Approval
10/22/2019	ZYPREXA RELPREVV NDA #022173	SUPPL-30	OLANZAPINE PAMOATE	CHEPLAPHARM	Labeling	Approval
10/22/2019	CLEOCIN ANDA #062644	SUPPL-28	CLINDAMYCIN PALMITATE HYDROCHLORIDE	PFIZER	Labeling	Approval
10/22/2019	CLEOCIN ANDA #062644	SUPPL-29	CLINDAMYCIN PALMITATE HYDROCHLORIDE	PFIZER	Labeling	Approval
10/22/2019	FAMOTIDINE ANDA #075400	SUPPL-35	FAMOTIDINE	PERRIGO	Labeling	Approval
10/22/2019	FAMOTIDINE ANDA #075511	SUPPL-23	FAMOTIDINE	IVAX SUB TEVA PHARMS	Labeling	Approval
10/22/2019	MELOXICAM ANDA #077918	SUPPL-5	MELOXICAM	YUNG SHIN PHARM	Labeling	Approval
10/22/2019	MELOXICAM ANDA #077918	SUPPL-6	MELOXICAM	YUNG SHIN PHARM	Labeling	Approval
10/22/2019	MELOXICAM ANDA #077927	SUPPL-26	MELOXICAM	UNICHEM	Labeling	Approval
10/22/2019	MELOXICAM ANDA #077929	SUPPL-6	MELOXICAM	CIPLA	Labeling	Approval
10/22/2019	MELOXICAM ANDA #077929	SUPPL-7	MELOXICAM	CIPLA	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078352	SUPPL-5	DESLORATADINE	LUPIN PHARMS	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078352	SUPPL-7	DESLORATADINE	LUPIN PHARMS	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078359	SUPPL-3	DESLORATADINE	SUN PHARM INDS	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078359	SUPPL-8	DESLORATADINE	SUN PHARM INDS	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078361	SUPPL-6	DESLORATADINE	PERRIGO	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078364	SUPPL-10	DESLORATADINE	CHARTWELL RX	Labeling	Approval
10/22/2019	DESLORATADINE ANDA #078367	SUPPL-5	DESLORATADINE	REDDYS	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #079103	SUPPL-14	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #079103	SUPPL-15	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #079142	SUPPL-14	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #079142	SUPPL-15	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	TRIAMCINOLONE ACETONIDE ANDA #090166	SUPPL-8	TRIAMCINOLONE ACETONIDE	SANDOZ	Labeling	Approval
10/22/2019	ERLOTINIB HYDROCHLORIDE ANDA #091002	SUPPL-2	ERLOTINIB HYDROCHLORIDE	RISING	Labeling	Approval
10/22/2019	ERLOTINIB HYDROCHLORIDE ANDA #091002	SUPPL-4	ERLOTINIB HYDROCHLORIDE	RISING	Labeling	Approval
10/22/2019	TACROLIMUS ANDA #091195	SUPPL-12	TACROLIMUS	ACCORD HLTHCARE	Labeling	Approval
10/22/2019	TACROLIMUS ANDA #091195	SUPPL-13	TACROLIMUS	ACCORD HLTHCARE	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #091650	SUPPL-11	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #091650	SUPPL-13	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #091650	SUPPL-15	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	CALCIPOTRIENE ANDA #200935	SUPPL-3	CALCIPOTRIENE	CHARTWELL RX	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #202357	SUPPL-8	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #202357	SUPPL-9	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #202357	SUPPL-11	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	ATORVASTATIN CALCIUM ANDA #202357	SUPPL-13	ATORVASTATIN CALCIUM	DR REDDYS LABS LTD	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #202776	SUPPL-8	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	MONTELUKAST SODIUM ANDA #202776	SUPPL-9	MONTELUKAST SODIUM	MYLAN PHARMS INC	Labeling	Approval
10/22/2019	FROVATRIPTAN SUCCINATE ANDA #202931	SUPPL-1	FROVATRIPTAN SUCCINATE	MYLAN	Labeling	Approval
10/22/2019	FROVATRIPTAN SUCCINATE ANDA #202931	SUPPL-4	FROVATRIPTAN SUCCINATE	MYLAN	Labeling	Approval
10/22/2019	VARDENAFIL HYDROCHLORIDE ANDA #204632	ORIG-1	VARDENAFIL HYDROCHLORIDE	MACLEODS PHARMS LTD		Approval
10/22/2019	FAMOTIDINE ANDA #206530	SUPPL-2	FAMOTIDINE	AUROBINDO PHARMA LTD	Labeling	Approval
10/22/2019	FAMOTIDINE ANDA #206530	SUPPL-4	FAMOTIDINE	AUROBINDO PHARMA LTD	Labeling	Approval
10/22/2019	LACTATED RINGER'S IN PLASTIC CONTAINER ANDA #209338	SUPPL-2	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	FRESENIUS KABI USA	Labeling	Approval
10/22/2019	DARIFENACIN HYDROBROMIDE ANDA #209571	ORIG-1	DARIFENACIN HYDROBROMIDE	XIROMED		Approval
10/22/2019	HALOPERIDOL DECANOATE ANDA #211180	ORIG-1	HALOPERIDOL DECANOATE	ZYDUS PHARMS		Approval
10/22/2019	SIROLIMUS ANDA #211406	ORIG-1	SIROLIMUS	APOTEX		Approval
10/23/2019	KEPPRA NDA #021035	SUPPL-102	LEVETIRACETAM	UCB INC	Efficacy	Approval
10/23/2019	KEPPRA NDA #021505	SUPPL-42	LEVETIRACETAM	UCB INC	Efficacy	Approval
10/23/2019	KEPPRA NDA #021872	SUPPL-28	LEVETIRACETAM	UCB INC	Efficacy	Approval
10/23/2019	OMNISCAN NDA #022066	SUPPL-10	GADODIAMIDE	GE HEALTHCARE	Labeling	Approval
10/23/2019	KEPPRA XR NDA #022285	SUPPL-28	LEVETIRACETAM	UCB INC	Efficacy	Approval
10/23/2019	MELOXICAM ANDA #077928	SUPPL-5	MELOXICAM	STRIDES PHARMA	Labeling	Approval
10/23/2019	KENGREAL NDA #204958	SUPPL-2	CANGRELOR	CHIESI	Labeling	Approval
10/23/2019	ZEJULA NDA #208447	SUPPL-14	NIRAPARIB TOSYLATE	GLAXOSMITHKLINE	Efficacy	Approval
10/23/2019	BIVALIRUDIN ANDA #210031	ORIG-1	BIVALIRUDIN	SHUANGCHENG		Approval
10/23/2019	ERYTHROMYCIN ETHYLSUCCINATE ANDA #211991	ORIG-1	ERYTHROMYCIN ETHYLSUCCINATE	PAR PHARM INC		Approval
10/23/2019	DESONIDE ANDA #212473	ORIG-1	DESONIDE	ALEMBIC		Approval
10/23/2019	EPHEDRINE SULFATE ANDA #212932	ORIG-1	EPHEDRINE SULFATE	AMNEAL		Approval
10/24/2019	CARDIOGEN-82 NDA #019414	SUPPL-24	RUBIDIUM CHLORIDE RB-82	BRACCO	Labeling	Approval
10/24/2019	BRILINTA NDA #022433	SUPPL-25	TICAGRELOR	ASTRAZENECA	Labeling	Approval
10/24/2019	AZITHROMYCIN ANDA #065179	SUPPL-13	AZITHROMYCIN	FRESENIUS KABI USA	Labeling	Approval
10/24/2019	AZITHROMYCIN ANDA #065179	SUPPL-16	AZITHROMYCIN	FRESENIUS KABI USA	Labeling	Approval
10/24/2019	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) ANDA #076703	SUPPL-27	DESMOPRESSIN ACETATE	APOTEX	Labeling	Approval
10/24/2019	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) ANDA #076703	SUPPL-31	DESMOPRESSIN ACETATE	APOTEX	Labeling	Approval
10/24/2019	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) ANDA #078271	SUPPL-17	DESMOPRESSIN ACETATE	SUN PHARM	Labeling	Approval
10/24/2019	METOPROLOL TARTRATE ANDA #078950	SUPPL-5	METOPROLOL TARTRATE	BAXTER HLTHCARE CORP	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #091154	SUPPL-2	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TEVA PHARMS USA	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #091154	SUPPL-3	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TEVA PHARMS USA	Labeling	Approval
10/24/2019	PALONOSETRON HYDROCHLORIDE ANDA #201533	SUPPL-1	PALONOSETRON HYDROCHLORIDE	DR REDDYS	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #202933	SUPPL-2	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TORRENT	Labeling	Approval
10/24/2019	FROVATRIPTAN SUCCINATE ANDA #204730	SUPPL-2	FROVATRIPTAN SUCCINATE	GLENMARK PHARMS LTD	Labeling	Approval
10/24/2019	TIVICAY NDA #204790	SUPPL-24	DOLUTEGRAVIR SODIUM	VIIV HLTHCARE	Labeling	Approval
10/24/2019	GALANTAMINE HYDROBROMIDE ANDA #204895	SUPPL-3	GALANTAMINE HYDROBROMIDE	AUROBINDO PHARMA	Labeling	Approval
10/24/2019	TRIUMEQ NDA #205551	SUPPL-22	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #206884	SUPPL-1	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	MACLEODS PHARMS LTD	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #206884	SUPPL-3	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	MACLEODS PHARMS LTD	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #207216	SUPPL-1	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	AJANTA PHARMA LTD	Labeling	Approval
10/24/2019	AMLODIPINE AND OLMESARTAN MEDOXOMIL ANDA #207216	SUPPL-2	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	AJANTA PHARMA LTD	Labeling	Approval
10/24/2019	BAXDELA NDA #208610	SUPPL-7	DELAFLOXACIN MEGLUMINE	MELINTA	Efficacy	Approval
10/24/2019	BAXDELA NDA #208611	SUPPL-6	DELAFLOXACIN MEGLUMINE	MELINTA	Efficacy	Approval
10/24/2019	JULUCA NDA #210192	SUPPL-8	DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE	VIIV HLTHCARE	Labeling	Approval
10/24/2019	DOVATO NDA #211994	SUPPL-5	DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Labeling	Approval
10/25/2019	OPANA NDA #021611	SUPPL-16	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Efficacy	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-13	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-14	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-15	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-17	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-18	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #076578	SUPPL-19	ZOLPIDEM TARTRATE	RISING	Labeling	Approval
10/25/2019	DESOGESTREL AND ETHINYL ESTRADIOL ANDA #077182	SUPPL-14	DESOGESTREL; ETHINYL ESTRADIOL	DR REDDYS LABS SA	Labeling	Approval
10/25/2019	DESOGESTREL; ETHINYL ESTRADIOL ANDA #077182	SUPPL-14	DESOGESTREL; ETHINYL ESTRADIOL	DR REDDYS LABS SA	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077388	SUPPL-1	ZOLPIDEM TARTRATE	CHARTWELL MOLECULAR	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077388	SUPPL-2	ZOLPIDEM TARTRATE	CHARTWELL MOLECULAR	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077388	SUPPL-3	ZOLPIDEM TARTRATE	CHARTWELL MOLECULAR	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077388	SUPPL-4	ZOLPIDEM TARTRATE	CHARTWELL MOLECULAR	Labeling	Approval
10/25/2019	ZONISAMIDE ANDA #077637	SUPPL-8	ZONISAMIDE	RISING	Labeling	Approval
10/25/2019	ZONISAMIDE ANDA #077641	SUPPL-4	ZONISAMIDE	ANI PHARMS	Labeling	Approval
10/25/2019	ZONISAMIDE ANDA #077813	SUPPL-6	ZONISAMIDE	BIONPHARMA	Labeling	Approval
10/25/2019	ZONISAMIDE ANDA #077876	SUPPL-3	ZONISAMIDE	EPIC PHARMA LLC	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077884	SUPPL-15	ZOLPIDEM TARTRATE	APOTEX INC	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077884	SUPPL-16	ZOLPIDEM TARTRATE	APOTEX INC	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077884	SUPPL-17	ZOLPIDEM TARTRATE	APOTEX INC	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077884	SUPPL-18	ZOLPIDEM TARTRATE	APOTEX INC	Labeling	Approval
10/25/2019	ZOLPIDEM TARTRATE ANDA #077884	SUPPL-19	ZOLPIDEM TARTRATE	APOTEX INC	Labeling	Approval
10/25/2019	GALANTAMINE HYDROBROMIDE ANDA #090900	SUPPL-8	GALANTAMINE HYDROBROMIDE	MYLAN	Labeling	Approval
10/25/2019	NAPROXEN ANDA #091305	SUPPL-11	NAPROXEN	INVAGEN PHARMS	Labeling	Approval
10/25/2019	NAPROXEN ANDA #091305	SUPPL-13	NAPROXEN	INVAGEN PHARMS	Labeling	Approval
10/25/2019	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) ANDA #091345	SUPPL-1	DESMOPRESSIN ACETATE	ZYDUS PHARMS	Labeling	Approval
10/25/2019	ITRACONAZOLE ANDA #203445	SUPPL-1	ITRACONAZOLE	JUBILANT GENERICS	Labeling	Approval
10/25/2019	ITRACONAZOLE ANDA #203445	SUPPL-2	ITRACONAZOLE	JUBILANT GENERICS	Labeling	Approval
10/25/2019	ITRACONAZOLE ANDA #203445	SUPPL-5	ITRACONAZOLE	JUBILANT GENERICS	Labeling	Approval
10/25/2019	DESVENLAFAXINE SUCCINATE ANDA #204805	SUPPL-1	DESVENLAFAXINE SUCCINATE	INTELLIPHARMACEUTICS	Manufacturing (CMC)	Approval
10/25/2019	LILETTA NDA #206229	SUPPL-8	LEVONORGESTREL	MEDICINES360	Efficacy	Approval
10/25/2019	SIMLIYA ANDA #206853	SUPPL-2	DESOGESTREL; ETHINYL ESTRADIOL	AUROBINDO PHARMA	Labeling	Approval
10/25/2019	FENOFIBRATE ANDA #209950	SUPPL-1	FENOFIBRATE	AMNEAL	Labeling	Approval
10/25/2019	FENOFIBRATE ANDA #209950	SUPPL-2	FENOFIBRATE	AMNEAL	Labeling	Approval
10/25/2019	FENOFIBRATE ANDA #209950	SUPPL-3	FENOFIBRATE	AMNEAL	Labeling	Approval
10/25/2019	AMANTADINE HYDROCHLORIDE ANDA #210403	SUPPL-1	AMANTADINE HYDROCHLORIDE	JUBILANT GENERICS	Labeling	Approval
10/25/2019	TEGSEDI NDA #211172	SUPPL-4	INOTERSEN SODIUM	AKCEA THERAPS	Labeling	Approval
10/25/2019	LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #211551	SUPPL-3	LEVOCETIRIZINE DIHYDROCHLORIDE	MICRO LABS	Manufacturing (CMC)	Approval
10/25/2019	ATORVASTATIN CALCIUM ANDA #211933	SUPPL-1	ATORVASTATIN CALCIUM	MSN	Labeling	Approval
10/25/2019	CLOBETASOL PROPIONATE ANDA #212926	ORIG-1	CLOBETASOL PROPIONATE	TORRENT		Approval
10/25/2019	KANJINTI BLA #761073	SUPPL-1	TRASTUZUMAB-ANNS	AMGEN INC		Approval
10/26/2019	NAPROXEN SODIUM NDA #021920	SUPPL-25	NAPROXEN SODIUM	BIONPHARMA	Labeling	Approval
10/27/2019	HELIUM, USP NDA #213990	ORIG-1	HELIUM	ILMO Products Company	Medical Gas	Approval
10/28/2019	CALAN SR NDA #019152	SUPPL-44	VERAPAMIL HYDROCHLORIDE	PFIZER	Labeling	Approval
10/28/2019	HUMATROPE BLA #019640	SUPPL-91	SOMATROPIN	LILLY		Approval
10/28/2019	HUMATROPE BLA #019640	SUPPL-105	SOMATROPIN	LILLY		Approval
10/28/2019	NIPENT NDA #020122	SUPPL-15	PENTOSTATIN	HOSPIRA INC	Labeling	Approval
10/28/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040432	SUPPL-13	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
10/28/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040482	SUPPL-21	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
10/28/2019	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040846	SUPPL-14	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	Labeling	Approval
10/28/2019	KETOROLAC TROMETHAMINE ANDA #076271	SUPPL-7	KETOROLAC TROMETHAMINE	SANDOZ	Labeling	Approval
10/28/2019	RISPERIDONE ANDA #078040	SUPPL-17	RISPERIDONE	ZYDUS PHARMS USA INC	Labeling	Approval
10/28/2019	RISPERIDONE ANDA #078040	SUPPL-18	RISPERIDONE	ZYDUS PHARMS USA INC	Labeling	Approval
10/28/2019	RISPERIDONE ANDA #078040	SUPPL-23	RISPERIDONE	ZYDUS PHARMS USA INC	Labeling	Approval
10/28/2019	RISPERIDONE ANDA #078040	SUPPL-24	RISPERIDONE	ZYDUS PHARMS USA INC	Labeling	Approval
10/28/2019	ERLOTINIB HYDROCHLORIDE ANDA #091059	SUPPL-2	ERLOTINIB HYDROCHLORIDE	TEVA PHARMS USA INC	Labeling	Approval
10/28/2019	PIMTREA ANDA #091247	SUPPL-3	DESOGESTREL; ETHINYL ESTRADIOL	NOVAST LABS	Labeling	Approval
10/28/2019	REPAGLINIDE ANDA #201189	SUPPL-5	REPAGLINIDE	PADAGIS US	Labeling	Approval
10/28/2019	REPAGLINIDE ANDA #201189	SUPPL-7	REPAGLINIDE	PADAGIS US	Labeling	Approval
10/28/2019	DOCETAXEL ANDA #203170	SUPPL-4	DOCETAXEL	HENGRUI PHARMA	Labeling	Approval
10/28/2019	DOCETAXEL ANDA #203170	SUPPL-7	DOCETAXEL	HENGRUI PHARMA	Labeling	Approval
10/28/2019	REPAGLINIDE ANDA #203820	SUPPL-4	REPAGLINIDE	AUROBINDO PHARMA LTD	Labeling	Approval
10/28/2019	REPAGLINIDE ANDA #203820	SUPPL-7	REPAGLINIDE	AUROBINDO PHARMA LTD	Labeling	Approval
10/28/2019	QUETIAPINE FUMARATE ANDA #206260	SUPPL-4	QUETIAPINE FUMARATE	PHARMADAX INC	Labeling	Approval
10/28/2019	KALLIGA ANDA #207081	SUPPL-1	DESOGESTREL; ETHINYL ESTRADIOL	AUROBINDO PHARMA	Labeling	Approval
10/28/2019	NAFTIFINE HYDROCHLORIDE ANDA #208201	SUPPL-1	NAFTIFINE HYDROCHLORIDE	TARO	Manufacturing (CMC)	Approval
10/28/2019	EPHEDRINE SULFATE ANDA #209784	SUPPL-1	EPHEDRINE SULFATE	SANDOZ	Labeling	Approval
10/28/2019	ALIQOPA NDA #209936	SUPPL-3	COPANLISIB DIHYDROCHLORIDE	BAYER HEALTHCARE	Labeling	Approval
10/28/2019	EMPLICITI BLA #761035	SUPPL-10	ELOTUZUMAB	BRISTOL MYERS SQUIBB		Approval
10/29/2019	MESTINON NDA #015193	SUPPL-27	PYRIDOSTIGMINE BROMIDE	BAUSCH	Labeling	Approval
10/29/2019	PEPCID AC NDA #020801	SUPPL-20	FAMOTIDINE	J AND J CONSUMER INC	Labeling	Approval
10/29/2019	SUSTIVA NDA #020972	SUPPL-57	EFAVIRENZ	BRISTOL MYERS SQUIBB	Labeling	Approval
10/29/2019	SUSTIVA NDA #021360	SUPPL-45	EFAVIRENZ	BRISTOL MYERS SQUIBB	Labeling	Approval
10/29/2019	RANEXA NDA #021526	SUPPL-35	RANOLAZINE	MENARINI INTL	Labeling	Approval
10/29/2019	DESMOPRESSIN ACETATE NDA #021795	SUPPL-6	DESMOPRESSIN ACETATE	FERRING	Labeling	Approval
10/29/2019	ATRIPLA NDA #021937	SUPPL-44	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	GILEAD SCIENCES	Labeling	Approval
10/29/2019	SYMFI NDA #022142	SUPPL-37	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	MYLAN LABS LTD	Labeling	Approval
10/29/2019	FLUOXETINE HYDROCHLORIDE ANDA #075207	SUPPL-24	FLUOXETINE HYDROCHLORIDE	MYLAN	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #077633	SUPPL-28	LAMOTRIGINE	ZYDUS PHARMS USA	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #077633	SUPPL-29	LAMOTRIGINE	ZYDUS PHARMS USA	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #077633	SUPPL-30	LAMOTRIGINE	ZYDUS PHARMS USA	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #077633	SUPPL-31	LAMOTRIGINE	ZYDUS PHARMS USA	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #077633	SUPPL-32	LAMOTRIGINE	ZYDUS PHARMS USA	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #078009	SUPPL-23	LAMOTRIGINE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #078009	SUPPL-24	LAMOTRIGINE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #078009	SUPPL-25	LAMOTRIGINE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #078009	SUPPL-26	LAMOTRIGINE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	LAMOTRIGINE ANDA #078009	SUPPL-27	LAMOTRIGINE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	BUDESONIDE ANDA #078949	SUPPL-10	BUDESONIDE	APOTEX INC	Labeling	Approval
10/29/2019	AMIODARONE HYDROCHLORIDE ANDA #079029	SUPPL-18	AMIODARONE HYDROCHLORIDE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	AMIODARONE HYDROCHLORIDE ANDA #079029	SUPPL-19	AMIODARONE HYDROCHLORIDE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	AMIODARONE HYDROCHLORIDE ANDA #079029	SUPPL-20	AMIODARONE HYDROCHLORIDE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	AMIODARONE HYDROCHLORIDE ANDA #079029	SUPPL-22	AMIODARONE HYDROCHLORIDE	ZYDUS PHARMS USA INC	Labeling	Approval
10/29/2019	TYLENOL W/ CODEINE NO. 1 ANDA #085055	SUPPL-64	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
10/29/2019	TYLENOL W/ CODEINE NO. 2 ANDA #085055	SUPPL-64	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
10/29/2019	TYLENOL W/ CODEINE NO. 3 ANDA #085055	SUPPL-64	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
10/29/2019	TYLENOL W/ CODEINE NO. 4 ANDA #085055	SUPPL-64	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
10/29/2019	SUMATRIPTAN SUCCINATE ANDA #090358	SUPPL-19	SUMATRIPTAN SUCCINATE	SUN PHARM	Manufacturing (CMC)	Approval
10/29/2019	MEFENAMIC ACID ANDA #090359	SUPPL-3	MEFENAMIC ACID	NOSTRUM LABS INC	Labeling	Approval
10/29/2019	MEFENAMIC ACID ANDA #091608	SUPPL-2	MEFENAMIC ACID	BELCHER	Labeling	Approval
10/29/2019	CAMPATH BLA #103948	SUPPL-5169	ALEMTUZUMAB	GENZYME		Approval
10/29/2019	CAMPATH BLA #103948	SUPPL-5170	ALEMTUZUMAB	GENZYME		Approval
10/29/2019	LEMTRADA BLA #103948	SUPPL-5169	ALEMTUZUMAB	GENZYME		Approval
10/29/2019	LEMTRADA BLA #103948	SUPPL-5170	ALEMTUZUMAB	GENZYME		Approval
10/29/2019	GLYDO ANDA #201094	SUPPL-6	LIDOCAINE HYDROCHLORIDE	SAGENT PHARMS INC	Labeling	Approval
10/29/2019	SUPRAX NDA #202091	SUPPL-9	CEFIXIME	LUPIN LTD	Labeling	Approval
10/29/2019	PALONOSETRON HYDROCHLORIDE ANDA #202521	SUPPL-3	PALONOSETRON HYDROCHLORIDE	SANDOZ	Labeling	Approval
10/29/2019	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #203082	SUPPL-6	LIDOCAINE HYDROCHLORIDE	EUGIA PHARMA	Labeling	Approval
10/29/2019	DESVENLAFAXINE NDA #204150	SUPPL-10	DESVENLAFAXINE	ALEMBIC PHARMS LTD	Labeling	Approval
10/29/2019	FLUOXETINE HYDROCHLORIDE ANDA #204597	SUPPL-3	FLUOXETINE HYDROCHLORIDE	SCIEGEN PHARMS INC	Labeling	Approval
10/29/2019	FLUOXETINE HYDROCHLORIDE ANDA #204597	SUPPL-4	FLUOXETINE HYDROCHLORIDE	SCIEGEN PHARMS INC	Labeling	Approval
10/29/2019	FLUOXETINE HYDROCHLORIDE ANDA #204597	SUPPL-5	FLUOXETINE HYDROCHLORIDE	SCIEGEN PHARMS INC	Labeling	Approval
10/29/2019	HALOPERIDOL DECANOATE ANDA #205241	SUPPL-2	HALOPERIDOL DECANOATE	GLAND PHARMA LTD	Labeling	Approval
10/29/2019	HALOPERIDOL DECANOATE ANDA #205241	SUPPL-4	HALOPERIDOL DECANOATE	GLAND PHARMA LTD	Labeling	Approval
10/29/2019	LIDOCAINE HYDROCHLORIDE ANDA #207182	SUPPL-3	LIDOCAINE HYDROCHLORIDE	EUGIA PHARMA	Labeling	Approval
10/29/2019	SYMFI LO NDA #208255	SUPPL-8	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	MYLAN	Labeling	Approval
10/29/2019	LIDOCAINE HYDROCHLORIDE ANDA #208474	SUPPL-1	LIDOCAINE HYDROCHLORIDE	B BRAUN MEDICAL INC	Labeling	Approval
10/29/2019	BIMATOPROST ANDA #209797	ORIG-1	BIMATOPROST	GLAND PHARMA LTD		Tentative Approval
10/29/2019	GLYCOPYRROLATE ANDA #210246	ORIG-1	GLYCOPYRROLATE	APOTEX		Approval
10/29/2019	RANOLAZINE ANDA #210482	ORIG-1	RANOLAZINE	ANI PHARMS		Approval
10/29/2019	TEMIXYS NDA #211284	SUPPL-2	LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	CHARTWELL RX	Labeling	Approval
10/29/2019	VUMERITY NDA #211855	ORIG-1	DIROXIMEL FUMARATE	BIOGEN INC	Type 2 - New Active Ingredient	Approval
10/30/2019	ACETADOTE NDA #021539	SUPPL-17	ACETYLCYSTEINE	CUMBERLAND PHARMS	Labeling	Approval
10/30/2019	REVLIMID NDA #021880	SUPPL-60	LENALIDOMIDE	BRISTOL MYERS SQUIBB	Labeling	Approval
10/30/2019	GLYBURIDE (MICRONIZED) ANDA #074686	SUPPL-28	GLYBURIDE	TEVA	Labeling	Approval
10/30/2019	GLYBURIDE (MICRONIZED) ANDA #074792	SUPPL-15	GLYBURIDE	MYLAN	Labeling	Approval
10/30/2019	GLYBURIDE (MICRONIZED) ANDA #075890	SUPPL-12	GLYBURIDE	HIKMA	Labeling	Approval
10/30/2019	PROPAFENONE HYDROCHLORIDE ANDA #076550	SUPPL-11	PROPAFENONE HYDROCHLORIDE	ANI PHARMS	Labeling	Approval
10/30/2019	METOPROLOL TARTRATE ANDA #078085	SUPPL-9	METOPROLOL TARTRATE	HOSPIRA	Labeling	Approval
10/30/2019	METOPROLOL TARTRATE ANDA #090386	SUPPL-3	METOPROLOL TARTRATE	AM REGENT	Labeling	Approval
10/30/2019	MEFENAMIC ACID ANDA #090562	SUPPL-4	MEFENAMIC ACID	MICRO LABS	Labeling	Approval
10/30/2019	MEFENAMIC ACID ANDA #090562	SUPPL-6	MEFENAMIC ACID	MICRO LABS	Labeling	Approval
10/30/2019	MEFENAMIC ACID ANDA #090562	SUPPL-7	MEFENAMIC ACID	MICRO LABS	Labeling	Approval
10/30/2019	METOCLOPRAMIDE HYDROCHLORIDE ANDA #091392	SUPPL-3	METOCLOPRAMIDE HYDROCHLORIDE	FRESENIUS KABI USA	Labeling	Approval
10/30/2019	PROPAFENONE HYDROCHLORIDE ANDA #202688	SUPPL-4	PROPAFENONE HYDROCHLORIDE	WATSON LABS INC	Labeling	Approval
10/30/2019	PROPAFENONE HYDROCHLORIDE ANDA #203803	SUPPL-3	PROPAFENONE HYDROCHLORIDE	MYLAN	Labeling	Approval
10/30/2019	FENOFIBRATE ANDA #204019	SUPPL-7	FENOFIBRATE	LUPIN LTD	Labeling	Approval
10/30/2019	FENOFIBRATE ANDA #204019	SUPPL-11	FENOFIBRATE	LUPIN LTD	Labeling	Approval
10/30/2019	FENOFIBRATE ANDA #204019	SUPPL-12	FENOFIBRATE	LUPIN LTD	Labeling	Approval
10/30/2019	DESVENLAFAXINE SUCCINATE ANDA #204020	SUPPL-1	DESVENLAFAXINE SUCCINATE	ZYDUS PHARMS	Labeling	Approval
10/30/2019	DESVENLAFAXINE SUCCINATE ANDA #204020	SUPPL-2	DESVENLAFAXINE SUCCINATE	ZYDUS PHARMS	Labeling	Approval
10/30/2019	DESVENLAFAXINE SUCCINATE ANDA #204020	SUPPL-3	DESVENLAFAXINE SUCCINATE	ZYDUS PHARMS	Labeling	Approval
10/30/2019	POMALYST NDA #204026	SUPPL-21	POMALIDOMIDE	BRISTOL	Labeling	Approval
10/30/2019	DESVENLAFAXINE SUCCINATE ANDA #204082	SUPPL-5	DESVENLAFAXINE SUCCINATE	HIKMA	Labeling	Approval
10/30/2019	DESVENLAFAXINE SUCCINATE ANDA #204083	SUPPL-4	DESVENLAFAXINE SUCCINATE	HIKMA	Labeling	Approval
10/30/2019	BELRAPZO NDA #205580	SUPPL-6	BENDAMUSTINE HYDROCHLORIDE	EAGLE PHARMS	Labeling	Approval
10/30/2019	PALONOSETRON HYDROCHLORIDE ANDA #206396	SUPPL-1	PALONOSETRON HYDROCHLORIDE	CIPLA	Labeling	Approval
10/30/2019	OXYBUTYNIN CHLORIDE ANDA #210611	ORIG-1	OXYBUTYNIN CHLORIDE	NOVAST LABS		Approval
10/30/2019	CLOBAZAM ANDA #212092	ORIG-1	CLOBAZAM	CHARTWELL MOLECULAR		Approval
10/30/2019	NAPROXEN SODIUM ANDA #212199	ORIG-1	NAPROXEN SODIUM	SCIEGEN PHARMS INC		Approval
10/30/2019	CAPTOPRIL ANDA #212223	ORIG-1	CAPTOPRIL	SETON PHARMS		Approval
10/30/2019	URSODIOL ANDA #212452	ORIG-1	URSODIOL	EYWA PHARMA		Approval
10/30/2019	OXERVATE BLA #761094	SUPPL-1	CENEGERMIN-BKBJ	DOMPE FARMACEUTICI		Approval
10/31/2019	SUBUTEX NDA #020732	SUPPL-20	BUPRENORPHINE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/31/2019	SUBOXONE NDA #020733	SUPPL-24	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/31/2019	SUBOXONE NDA #022410	SUPPL-34	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	INDIVIOR	Labeling	Approval
10/31/2019	PROPAFENONE HYDROCHLORIDE ANDA #075998	SUPPL-20	PROPAFENONE HYDROCHLORIDE	SUN PHARM INDUSTRIES	Labeling	Approval
10/31/2019	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY ANDA #076447	SUPPL-26	FEXOFENADINE HYDROCHLORIDE	TEVA	Labeling	Approval
10/31/2019	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES ANDA #076447	SUPPL-26	FEXOFENADINE HYDROCHLORIDE	TEVA	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE ANDA #076447	SUPPL-26	FEXOFENADINE HYDROCHLORIDE	TEVA	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE ALLERGY ANDA #076447	SUPPL-26	FEXOFENADINE HYDROCHLORIDE	TEVA	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE HIVES ANDA #076447	SUPPL-26	FEXOFENADINE HYDROCHLORIDE	TEVA	Labeling	Approval
10/31/2019	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY ANDA #077081	SUPPL-16	FEXOFENADINE HYDROCHLORIDE	RISING	Labeling	Approval
10/31/2019	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES ANDA #077081	SUPPL-16	FEXOFENADINE HYDROCHLORIDE	RISING	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE ANDA #077081	SUPPL-16	FEXOFENADINE HYDROCHLORIDE	RISING	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE ALLERGY ANDA #077081	SUPPL-16	FEXOFENADINE HYDROCHLORIDE	RISING	Labeling	Approval
10/31/2019	FEXOFENADINE HYDROCHLORIDE HIVES ANDA #077081	SUPPL-16	FEXOFENADINE HYDROCHLORIDE	RISING	Labeling	Approval
10/31/2019	WARFARIN SODIUM ANDA #202202	SUPPL-2	WARFARIN SODIUM	AMNEAL PHARMS	Labeling	Approval
10/31/2019	WARFARIN SODIUM ANDA #202202	SUPPL-3	WARFARIN SODIUM	AMNEAL PHARMS	Labeling	Approval
10/31/2019	WARFARIN SODIUM ANDA #202202	SUPPL-4	WARFARIN SODIUM	AMNEAL PHARMS	Labeling	Approval
10/31/2019	ACETAMINOPHEN ANDA #204052	SUPPL-1	ACETAMINOPHEN	SANDOZ	Labeling	Approval
10/31/2019	DESVENLAFAXINE SUCCINATE ANDA #204095	SUPPL-1	DESVENLAFAXINE SUCCINATE	MYLAN	Labeling	Approval
10/31/2019	DESVENLAFAXINE SUCCINATE ANDA #204095	SUPPL-2	DESVENLAFAXINE SUCCINATE	MYLAN	Labeling	Approval
10/31/2019	DESVENLAFAXINE SUCCINATE ANDA #204095	SUPPL-3	DESVENLAFAXINE SUCCINATE	MYLAN	Labeling	Approval
10/31/2019	DESVENLAFAXINE SUCCINATE ANDA #204095	SUPPL-4	DESVENLAFAXINE SUCCINATE	MYLAN	Labeling	Approval
10/31/2019	PROPAFENONE HYDROCHLORIDE ANDA #205268	SUPPL-1	PROPAFENONE HYDROCHLORIDE	GLENMARK PHARMS LTD	Labeling	Approval
10/31/2019	NICOTINE POLACRILEX ANDA #208875	ORIG-1	NICOTINE POLACRILEX	P AND L		Approval
10/31/2019	VENLAFAXINE HYDROCHLORIDE ANDA #209193	ORIG-1	VENLAFAXINE HYDROCHLORIDE	DEXCEL		Approval
10/31/2019	NICOTINE POLACRILEX ANDA #209520	ORIG-1	NICOTINE POLACRILEX	P AND L		Approval
10/31/2019	RANOLAZINE ANDA #210054	SUPPL-4	RANOLAZINE	AJANTA PHARMA LTD	Labeling	Approval
10/31/2019	NICOTINE POLACRILEX ANDA #210711	ORIG-1	NICOTINE POLACRILEX	P AND L		Approval
10/31/2019	RANOLAZINE ANDA #211291	SUPPL-1	RANOLAZINE	CIPLA	Labeling	Approval
10/31/2019	RANOLAZINE ANDA #211707	SUPPL-1	RANOLAZINE	SUN PHARM	Labeling	Approval
10/31/2019	OXYCODONE AND ACETAMINOPHEN ANDA #211708	ORIG-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	GRANULES		Approval

All Approvals and Tentative Approvals October 2019

All Approvals and Tentative Approvals
October 2019