Drugs@FDA: FDA-Approved Drugs

All Approvals and Tentative Approvals
September 2018

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 September 25, 2024.

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Approval Date	Drug Name	Submission	Active Ingredients	Company	Submission Classification *	Submission Status
09/01/2018	AVEED NDA #022219	SUPPL-11	TESTOSTERONE UNDECANOATE	ENDO OPERATIONS	REMS	Approval
09/04/2018	SUMATRIPTAN AND NAPROXEN SODIUM ANDA #090872	ORIG-1	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	RISING PHARMA		Approval
09/04/2018	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM ANDA #202461	ORIG-1	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	DR REDDYS LABS LTD		Tentative Approval
09/04/2018	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #203041	ORIG-1	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	AUROBINDO PHARMA		Approval
09/04/2018	TICAGRELOR ANDA #208390	ORIG-1	TICAGRELOR	WATSON LABS INC		Approval
09/04/2018	FIASP BLA #208751	SUPPL-5	INSULIN ASPART	NOVO		Approval
09/04/2018	FIASP FLEXTOUCH BLA #208751	SUPPL-5	INSULIN ASPART	NOVO		Approval
09/04/2018	FIASP PENFILL BLA #208751	SUPPL-5	INSULIN ASPART	NOVO		Approval
09/04/2018	TERIFLUNOMIDE ANDA #209700	ORIG-1	TERIFLUNOMIDE	TEVA PHARMS USA		Approval
09/04/2018	BEXAROTENE ANDA #210105	ORIG-1	BEXAROTENE	AMNEAL PHARMS NY		Approval
09/05/2018	HYCAMTIN NDA #020671	SUPPL-23	TOPOTECAN HYDROCHLORIDE	SANDOZ	Labeling	Approval
09/05/2018	HYCAMTIN NDA #020981	SUPPL-8	TOPOTECAN HYDROCHLORIDE	SANDOZ	Labeling	Approval
09/05/2018	WARFARIN SODIUM ANDA #040616	SUPPL-9	WARFARIN SODIUM	PLIVA	Labeling	Approval
09/05/2018	WARFARIN SODIUM ANDA #040616	SUPPL-12	WARFARIN SODIUM	PLIVA	Labeling	Approval
09/05/2018	WARFARIN SODIUM ANDA #040616	SUPPL-14	WARFARIN SODIUM	PLIVA	Labeling	Approval
09/05/2018	WARFARIN SODIUM ANDA #040616	SUPPL-15	WARFARIN SODIUM	PLIVA	Labeling	Approval
09/05/2018	WARFARIN SODIUM ANDA #040616	SUPPL-16	WARFARIN SODIUM	PLIVA	Manufacturing (CMC)	Approval
09/05/2018	KETOROLAC TROMETHAMINE ANDA #076109	SUPPL-12	KETOROLAC TROMETHAMINE	APOTEX INC	Manufacturing (CMC)	Approval
09/05/2018	BASAGLAR BLA #205692	SUPPL-19	INSULIN GLARGINE	ELI LILLY AND CO		Approval
09/05/2018	TIGLUTIK KIT NDA #209080	ORIG-1	RILUZOLE	ITALFARMACO SA	Type 3 - New Dosage Form	Approval
09/05/2018	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE ANDA #209837	ORIG-1	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	PERRIGO R AND D		Approval
09/06/2018	ASTELIN NDA #020114	SUPPL-28	AZELASTINE HYDROCHLORIDE	NORVIUM BIOSCIENCE	Labeling	Approval
09/06/2018	ASTEPRO NDA #022203	SUPPL-15	AZELASTINE HYDROCHLORIDE	MYLAN SPECIALITY LP	Labeling	Approval
09/06/2018	DYMISTA NDA #202236	SUPPL-10	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	MYLAN SPECIALITY LP	Labeling	Approval
09/06/2018	TIVICAY NDA #204790	SUPPL-16	DOLUTEGRAVIR SODIUM	VIIV HLTHCARE	Labeling	Approval
09/06/2018	TIVICAY NDA #204790	SUPPL-18	DOLUTEGRAVIR SODIUM	VIIV HLTHCARE	Labeling	Approval
09/06/2018	TRIUMEQ NDA #205551	SUPPL-14	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Labeling	Approval
09/06/2018	TRIUMEQ NDA #205551	SUPPL-15	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE	VIIV HLTHCARE	Labeling	Approval
09/06/2018	OXYBUTYNIN CHLORIDE ANDA #210125	ORIG-1	OXYBUTYNIN CHLORIDE	TULEX PHARMS INC		Approval
09/06/2018	JULUCA NDA #210192	SUPPL-2	DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE	VIIV HLTHCARE	Labeling	Approval
09/06/2018	JULUCA NDA #210192	SUPPL-4	DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE	VIIV HLTHCARE	Labeling	Approval
09/07/2018	COPAXONE NDA #020622	SUPPL-104	GLATIRAMER ACETATE	TEVA PHARMS USA	Labeling	Approval
09/07/2018	PREZISTA NDA #021976	SUPPL-51	DARUNAVIR	JANSSEN PRODS	Labeling	Approval
09/07/2018	LAMIVUDINE AND ZIDOVUDINE ANDA #077411	ORIG-1	LAMIVUDINE; ZIDOVUDINE	CIPLA		Approval
09/07/2018	PREZISTA NDA #202895	SUPPL-22	DARUNAVIR	JANSSEN PRODS	Labeling	Approval
09/07/2018	OCTREOTIDE ACETATE ANDA #203765	ORIG-1	OCTREOTIDE ACETATE	HERITAGE		Approval
09/07/2018	PREZCOBIX NDA #205395	SUPPL-10	COBICISTAT; DARUNAVIR	JANSSEN PRODS	Labeling	Approval
09/07/2018	CASSIPA NDA #208042	ORIG-1	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TEVA PHARMS USA	Type 5 - New Formulation or New Manufacturer	Approval
09/07/2018	SITAGLIPTIN PHOSPHATE ANDA #208186	ORIG-1	SITAGLIPTIN PHOSPHATE	ZYDUS PHARMS USA INC		Tentative Approval
09/07/2018	VENCLEXTA NDA #208573	SUPPL-7	VENETOCLAX	ABBVIE	Efficacy	Approval
09/07/2018	VENCLEXTA NDA #208573	SUPPL-10	VENETOCLAX	ABBVIE	Labeling	Approval
09/10/2018	RETROVIR NDA #019655	SUPPL-58	ZIDOVUDINE	VIIV HLTHCARE	Labeling	Approval
09/10/2018	RETROVIR NDA #019910	SUPPL-45	ZIDOVUDINE	VIIV HLTHCARE	Labeling	Approval
09/10/2018	RETROVIR NDA #019951	SUPPL-36	ZIDOVUDINE	VIIV HLTHCARE	Labeling	Approval
09/10/2018	IBUPROFEN ANDA #204062	ORIG-1	IBUPROFEN	SUNSHINE		Approval
09/10/2018	METFORMIN HYDROCHLORIDE ANDA #208880	ORIG-1	METFORMIN HYDROCHLORIDE	PRINSTON INC		Approval
09/10/2018	CHLORPROMAZINE HYDROCHLORIDE ANDA #209755	ORIG-1	CHLORPROMAZINE HYDROCHLORIDE	AMNEAL PHARMS CO		Approval
09/10/2018	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #209932	ORIG-1	MAGNESIUM SULFATE	MYLAN LABS LTD		Approval
09/10/2018	DROSPIRENONE AND ETHINYL ESTRADIOL ANDA #210017	ORIG-1	DROSPIRENONE; ETHINYL ESTRADIOL	JUBILANT CADISTA		Approval
09/10/2018	FENOFIBRATE (MICRONIZED) ANDA #210705	ORIG-1	FENOFIBRATE	AJANTA PHARMA LTD		Approval
09/10/2018	METHYLERGONOVINE MALEATE ANDA #211483	ORIG-1	METHYLERGONOVINE MALEATE	AMNEAL PHARMS		Approval
09/10/2018	OXYGEN, USP NDA #211739	ORIG-1	OXYGEN	CRISTAL ASU LLC	Medical Gas	Approval
09/11/2018	OXYCODONE AND ASPIRIN ANDA #090084	SUPPL-6	ASPIRIN; OXYCODONE HYDROCHLORIDE	ACTAVIS LABS FL INC	Labeling	Approval
09/11/2018	RISEDRONATE SODIUM ANDA #203822	ORIG-1	RISEDRONATE SODIUM	ZYDUS PHARMS		Approval
09/11/2018	TRAMADOL HYDROCHLORIDE ANDA #204421	SUPPL-5	TRAMADOL HYDROCHLORIDE	AUROBINDO PHARMA LTD	Labeling	Approval
09/11/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206142	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	Labeling	Approval
09/11/2018	ATOVAQUONE ANDA #209105	ORIG-1	ATOVAQUONE	LUPIN LTD		Approval
09/11/2018	CARMUSTINE ANDA #210179	ORIG-1	CARMUSTINE	NAVINTA LLC		Approval
09/12/2018	INVANZ NDA #021337	SUPPL-46	ERTAPENEM SODIUM	MSD SUB MERCK	Labeling	Approval
09/12/2018	CADUET NDA #021540	SUPPL-42	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	PHARMACIA	Labeling	Approval
09/12/2018	CADUET NDA #021540	SUPPL-43	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	PHARMACIA	Labeling	Approval
09/12/2018	BOTOX BLA #103000	SUPPL-5308	OnabotulinumtoxinA	ALLERGAN		Approval
09/12/2018	BOTOX COSMETIC BLA #103000	SUPPL-5308	OnabotulinumtoxinA	ALLERGAN		Approval
09/12/2018	ACTEMRA BLA #125276	SUPPL-122	TOCILIZUMAB	GENENTECH		Approval
09/12/2018	ACTEMRA BLA #125472	SUPPL-31	TOCILIZUMAB	GENENTECH		Approval
09/12/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202214	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TRIS PHARMA INC	Labeling	Approval
09/12/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202214	SUPPL-7	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TRIS PHARMA INC	Labeling	Approval
09/12/2018	TRANEXAMIC ACID ANDA #202755	SUPPL-1	TRANEXAMIC ACID	CHARTWELL RX	Manufacturing (CMC)	Approval
09/12/2018	XELPROS NDA #206185	ORIG-1	LATANOPROST	SUN PHARM	Type 3 - New Dosage Form	Approval
09/12/2018	SPRITAM NDA #207958	SUPPL-8	LEVETIRACETAM	APRECIA PHARMS	Labeling	Approval
09/12/2018	ALOGLIPTIN;METFORMIN HYDROCHLORIDE ANDA #210173	ORIG-1	ALOGLIPTIN;METFORMIN HYDROCHLORIDE	ALEMBIC PHARMS LTD		Tentative Approval
09/13/2018	DESOGESTREL AND ETHINYL ESTRADIOL ANDA #207067	ORIG-1	DESOGESTREL; ETHINYL ESTRADIOL	NAARI PTE LTD		Approval
09/13/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207709	ORIG-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC		Approval
09/13/2018	LUMOXITI BLA #761104	ORIG-1	MOXETUMOMAB PASUDOTOX-TDFK	INNATE PHARMA		Approval
09/14/2018	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER NDA #019022	SUPPL-31	SODIUM CHLORIDE	BAXTER HLTHCARE	Labeling	Approval
09/14/2018	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER NDA #019022	SUPPL-31	SODIUM CHLORIDE	BAXTER HLTHCARE	Labeling	Approval
09/14/2018	AMBIEN NDA #019908	SUPPL-42	ZOLPIDEM TARTRATE	SANOFI AVENTIS US	Labeling	Approval
09/14/2018	EUTHYROX NDA #021292	SUPPL-4	LEVOTHYROXINE SODIUM	PROVELL	Efficacy	Approval
09/14/2018	EUTHYROX NDA #021292	SUPPL-5	LEVOTHYROXINE SODIUM	PROVELL	Labeling	Approval
09/14/2018	EUTHYROX NDA #021292	SUPPL-6	LEVOTHYROXINE SODIUM	PROVELL	Labeling	Approval
09/14/2018	AMBIEN CR NDA #021774	SUPPL-23	ZOLPIDEM TARTRATE	SANOFI AVENTIS US	Labeling	Approval
09/14/2018	HYDROCODONE ANDA #077723	SUPPL-19	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/14/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723	SUPPL-19	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/14/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #091633	SUPPL-3	HYDROCODONE BITARTRATE; IBUPROFEN	SUN PHARM INDS INC	Labeling	Approval
09/14/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #091633	SUPPL-8	HYDROCODONE BITARTRATE; IBUPROFEN	SUN PHARM INDS INC	Labeling	Approval
09/14/2018	SYNDROS NDA #205525	SUPPL-7	DRONABINOL	BENUVIA OPERATIONS	Labeling	Approval
09/14/2018	EPLERENONE ANDA #208283	ORIG-1	EPLERENONE	BRECKENRIDGE		Approval
09/14/2018	SEIZALAM NDA #209566	ORIG-1	MIDAZOLAM HYDROCHLORIDE	MMT	Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated	Approval
09/14/2018	MAGNESIUM SULFATE IN PLASTIC CONTAINER ANDA #209911	ORIG-1	MAGNESIUM SULFATE	MYLAN LABS LTD		Approval
09/14/2018	ESTRADIOL ANDA #210264	ORIG-1	ESTRADIOL	GLENMARK PHARMS LTD		Approval
09/14/2018	CLOFARABINE ANDA #210270	ORIG-1	CLOFARABINE	NOVAST LABS		Approval
09/14/2018	LEVOLEUCOVORIN CALCIUM ANDA #210892	ORIG-1	LEVOLEUCOVORIN CALCIUM	GLAND PHARMA LTD		Approval
09/14/2018	AJOVY BLA #761089	ORIG-1	FREMANEZUMAB-VFRM	TEVA PHARMS USA		Approval
09/17/2018	RITONAVIR ANDA #204587	ORIG-1	RITONAVIR	HETERO LABS LTD III		Approval
09/17/2018	RITONAVIR ANDA #206614	ORIG-1	RITONAVIR	AUROBINDO PHARMA LTD		Approval
09/17/2018	RITONAVIR ANDA #208890	ORIG-1	RITONAVIR	AMNEAL		Approval
09/18/2018	DEMEROL NDA #005010	SUPPL-56	MEPERIDINE HYDROCHLORIDE	VALIDUS PHARMS	REMS	Approval
09/18/2018	DEMEROL NDA #005010	SUPPL-57	MEPERIDINE HYDROCHLORIDE	VALIDUS PHARMS	Labeling	Approval
09/18/2018	DOLOPHINE HYDROCHLORIDE NDA #006134	SUPPL-46	METHADONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	DOLOPHINE HYDROCHLORIDE NDA #006134	SUPPL-48	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/18/2018	PERCODAN NDA #007337	SUPPL-50	ASPIRIN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	PERCODAN NDA #007337	SUPPL-51	ASPIRIN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/18/2018	PERCODAN NDA #007337	SUPPL-50	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO OPERATIONS	REMS	Approval
09/18/2018	PERCODAN NDA #007337	SUPPL-51	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO OPERATIONS	Labeling	Approval
09/18/2018	PERCODAN-DEMI NDA #007337	SUPPL-50	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO OPERATIONS	REMS	Approval
09/18/2018	PERCODAN-DEMI NDA #007337	SUPPL-51	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ENDO OPERATIONS	Labeling	Approval
09/18/2018	SYNALGOS-DC NDA #011483	SUPPL-31	ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	SYNALGOS-DC NDA #011483	SUPPL-32	ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE	SUN PHARM INDUSTRIES	Labeling	Approval
09/18/2018	FIORINAL W/CODEINE NDA #019429	SUPPL-41	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ALLERGAN	REMS	Approval
09/18/2018	FIORINAL W/CODEINE NDA #019429	SUPPL-42	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ALLERGAN	Labeling	Approval
09/18/2018	MS CONTIN NDA #019516	SUPPL-53	MORPHINE SULFATE	PURDUE PHARMA LP	REMS	Approval
09/18/2018	MS CONTIN NDA #019516	SUPPL-54	MORPHINE SULFATE	PURDUE PHARMA LP	Labeling	Approval
09/18/2018	DURAGESIC-100 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-100 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DURAGESIC-12 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-12 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DURAGESIC-25 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-25 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DURAGESIC-37 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-37 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DURAGESIC-50 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-50 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DURAGESIC-75 NDA #019813	SUPPL-75	FENTANYL	JANSSEN PHARMS	REMS	Approval
09/18/2018	DURAGESIC-75 NDA #019813	SUPPL-76	FENTANYL	JANSSEN PHARMS	Labeling	Approval
09/18/2018	DILAUDID NDA #019891	SUPPL-26	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	REMS	Approval
09/18/2018	DILAUDID NDA #019891	SUPPL-27	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
09/18/2018	DILAUDID NDA #019892	SUPPL-33	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	REMS	Approval
09/18/2018	DILAUDID NDA #019892	SUPPL-34	HYDROMORPHONE HYDROCHLORIDE	RHODES PHARMS	Labeling	Approval
09/18/2018	FIORICET W/ CODEINE NDA #020232	SUPPL-42	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ACTAVIS LABS UT INC	REMS	Approval
09/18/2018	FIORICET W/ CODEINE NDA #020232	SUPPL-43	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	ACTAVIS LABS UT INC	Labeling	Approval
09/18/2018	ULTRAM NDA #020281	SUPPL-42	TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	REMS	Approval
09/18/2018	ULTRAM NDA #020281	SUPPL-43	TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
09/18/2018	KADIAN NDA #020616	SUPPL-61	MORPHINE SULFATE	ALLERGAN	REMS	Approval
09/18/2018	KADIAN NDA #020616	SUPPL-62	MORPHINE SULFATE	ALLERGAN	Labeling	Approval
09/18/2018	ROXICODONE NDA #021011	SUPPL-8	OXYCODONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	ROXICODONE NDA #021011	SUPPL-9	OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/18/2018	ULTRACET NDA #021123	SUPPL-16	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	REMS	Approval
09/18/2018	ULTRACET NDA #021123	SUPPL-17	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	JANSSEN PHARMS	Labeling	Approval
09/18/2018	EXALGO NDA #021217	SUPPL-23	HYDROMORPHONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	EXALGO NDA #021217	SUPPL-24	HYDROMORPHONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/18/2018	BUTRANS NDA #021306	SUPPL-32	BUPRENORPHINE	PURDUE PHARMA LP	REMS	Approval
09/18/2018	BUTRANS NDA #021306	SUPPL-34	BUPRENORPHINE	PURDUE PHARMA LP	Labeling	Approval
09/18/2018	OPANA ER NDA #021610	SUPPL-25	OXYMORPHONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	OPANA ER NDA #021610	SUPPL-26	OXYMORPHONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/18/2018	OPANA NDA #021611	SUPPL-13	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	REMS	Approval
09/18/2018	OPANA NDA #021611	SUPPL-15	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
09/18/2018	MORPHINE SULFATE NDA #022195	SUPPL-14	MORPHINE SULFATE	HIKMA	REMS	Approval
09/18/2018	MORPHINE SULFATE NDA #022195	SUPPL-16	MORPHINE SULFATE	HIKMA	Labeling	Approval
09/18/2018	MORPHINE SULFATE NDA #022207	SUPPL-7	MORPHINE SULFATE	HIKMA	REMS	Approval
09/18/2018	MORPHINE SULFATE NDA #022207	SUPPL-8	MORPHINE SULFATE	HIKMA	Labeling	Approval
09/18/2018	OXYCONTIN NDA #022272	SUPPL-40	OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	REMS	Approval
09/18/2018	OXYCONTIN NDA #022272	SUPPL-41	OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	Labeling	Approval
09/18/2018	NUCYNTA NDA #022304	SUPPL-19	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	REMS	Approval
09/18/2018	NUCYNTA NDA #022304	SUPPL-21	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
09/18/2018	EMBEDA NDA #022321	SUPPL-28	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	ALPHARMA PHARMS	REMS	Approval
09/18/2018	EMBEDA NDA #022321	SUPPL-29	MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE	ALPHARMA PHARMS	Labeling	Approval
09/18/2018	CONZIP NDA #022370	SUPPL-16	TRAMADOL HYDROCHLORIDE	CIPHER PHARMS INC	REMS	Approval
09/18/2018	CONZIP NDA #022370	SUPPL-17	TRAMADOL HYDROCHLORIDE	CIPHER PHARMS INC	Labeling	Approval
09/18/2018	CODEINE SULFATE NDA #022402	SUPPL-10	CODEINE SULFATE	HIKMA	REMS	Approval
09/18/2018	CODEINE SULFATE NDA #022402	SUPPL-11	CODEINE SULFATE	HIKMA	Labeling	Approval
09/18/2018	METHADOSE ANDA #040050	SUPPL-27	METHADONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	NORCO ANDA #040099	SUPPL-21	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040105	SUPPL-31	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040110	SUPPL-6	MEPERIDINE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040118	SUPPL-17	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	SANDOZ	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040119	SUPPL-13	ACETAMINOPHEN; CODEINE PHOSPHATE	PAI HOLDINGS	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040148	SUPPL-71	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	REMS	Approval
09/18/2018	NORCO ANDA #040148	SUPPL-71	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040171	SUPPL-33	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040186	SUPPL-9	MEPERIDINE HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040191	SUPPL-14	MEPERIDINE HYDROCHLORIDE	STRIDES PHARMA	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040203	SUPPL-9	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #040241	SUPPL-19	METHADONE HYDROCHLORIDE	VISTAPHARM LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040248	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	REMS	Approval
09/18/2018	OXYCODONE AND ASPIRIN ANDA #040255	SUPPL-27	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ANI PHARMS	REMS	Approval
09/18/2018	OXYCODONE AND ASPIRIN ANDA #040260	SUPPL-15	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	PERCOCET ANDA #040330	SUPPL-50	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040331	SUPPL-16	MEPERIDINE HYDROCHLORIDE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040352	SUPPL-5	MEPERIDINE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040355	SUPPL-35	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040400	SUPPL-27	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	REMS	Approval
09/18/2018	ANEXSIA 7.5/325 ANDA #040405	SUPPL-27	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	REMS	Approval
09/18/2018	ANEXSIA 5/325 ANDA #040409	SUPPL-27	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040419	SUPPL-24	ACETAMINOPHEN; CODEINE PHOSPHATE	SPECGX LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040432	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040446	SUPPL-11	MEPERIDINE HYDROCHLORIDE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040482	SUPPL-19	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #040517	SUPPL-25	METHADONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040535	SUPPL-33	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040545	SUPPL-15	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040608	SUPPL-13	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MIKART	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040655	SUPPL-25	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040656	SUPPL-25	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040658	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040680	SUPPL-11	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040736	SUPPL-18	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040746	SUPPL-20	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040777	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040778	SUPPL-16	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040779	SUPPL-19	ACETAMINOPHEN; CODEINE PHOSPHATE	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040800	SUPPL-5	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040826	SUPPL-9	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS LTD	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040834	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040838	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040846	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	REMS	Approval
09/18/2018	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040860	SUPPL-3	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	INGENUS PHARMS NJ	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040881	SUPPL-10	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #040893	SUPPL-4	MEPERIDINE HYDROCHLORIDE	GENUS	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040894	SUPPL-10	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	REMS	Approval
09/18/2018	METHADOSE ANDA #074184	SUPPL-22	METHADONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	LEVORPHANOL TARTRATE ANDA #074278	SUPPL-12	LEVORPHANOL TARTRATE	HIKMA	REMS	Approval
09/18/2018	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANDA #074359	SUPPL-14	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	WATSON LABS	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #074597	SUPPL-15	HYDROMORPHONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #074653	SUPPL-9	HYDROMORPHONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #074736	SUPPL-33	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #074769	SUPPL-29	MORPHINE SULFATE	RHODES PHARMS	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #074862	SUPPL-28	MORPHINE SULFATE	RHODES PHARMS	REMS	Approval
09/18/2018	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANDA #074951	SUPPL-4	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	STEVENS J	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #075082	SUPPL-8	METHADONE HYDROCHLORIDE	VISTAPHARM	REMS	Approval
09/18/2018	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANDA #075231	SUPPL-8	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	LGM PHARMA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #075295	SUPPL-51	MORPHINE SULFATE	STRIDES PHARMA	REMS	Approval
09/18/2018	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANDA #075351	SUPPL-5	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	STRIDES PHARMA	REMS	Approval
09/18/2018	BUTORPHANOL TARTRATE ANDA #075499	SUPPL-24	BUTORPHANOL TARTRATE	APOTEX	REMS	Approval
09/18/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075523	SUPPL-3	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	SUN PHARM INDS LTD	REMS	Approval
09/18/2018	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ANDA #075618	SUPPL-27	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	HIKMA INTL PHARMS	REMS	Approval
09/18/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075735	SUPPL-13	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	LUPIN	REMS	Approval
09/18/2018	BUTORPHANOL TARTRATE ANDA #075759	SUPPL-28	BUTORPHANOL TARTRATE	RISING	REMS	Approval
09/18/2018	BUTORPHANOL TARTRATE ANDA #075824	SUPPL-11	BUTORPHANOL TARTRATE	HIKMA	REMS	Approval
09/18/2018	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ANDA #075929	SUPPL-24	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	NOSTRUM LABS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075962	SUPPL-9	TRAMADOL HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075964	SUPPL-31	TRAMADOL HYDROCHLORIDE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075968	SUPPL-11	TRAMADOL HYDROCHLORIDE	GRAVITI PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075977	SUPPL-17	TRAMADOL HYDROCHLORIDE	TEVA	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075980	SUPPL-4	TRAMADOL HYDROCHLORIDE	MYLAN PHARMS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075981	SUPPL-18	TRAMADOL HYDROCHLORIDE	APOTEX	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075982	SUPPL-14	TRAMADOL HYDROCHLORIDE	PLIVA	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075983	SUPPL-12	TRAMADOL HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #075986	SUPPL-18	TRAMADOL HYDROCHLORIDE	MYLAN	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #076003	SUPPL-37	TRAMADOL HYDROCHLORIDE	AMNEAL PHARMS	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076023	SUPPL-19	HYDROCODONE BITARTRATE; IBUPROFEN	TEVA	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #076100	SUPPL-23	TRAMADOL HYDROCHLORIDE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	FENTANYL-100 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-12 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-37 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-62 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	FENTANYL-87 ANDA #076258	SUPPL-37	FENTANYL	MYLAN TECHNOLOGIES	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #076412	SUPPL-28	MORPHINE SULFATE	SPECGX LLC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #076438	SUPPL-25	MORPHINE SULFATE	SPECGX LLC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #076475	SUPPL-19	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	CHARTWELL RX	REMS	Approval
09/18/2018	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ANDA #076560	SUPPL-8	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	LGM PHARMA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076604	SUPPL-20	HYDROCODONE BITARTRATE; IBUPROFEN	ACTAVIS LABS FL INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #076636	SUPPL-35	OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076642	SUPPL-25	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	REPREXAIN ANDA #076642	SUPPL-25	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	FENTANYL-100 ANDA #076709	SUPPL-31	FENTANYL	ACTAVIS LABS UT INC	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #076709	SUPPL-31	FENTANYL	ACTAVIS LABS UT INC	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #076709	SUPPL-31	FENTANYL	ACTAVIS LABS UT INC	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #076709	SUPPL-31	FENTANYL	ACTAVIS LABS UT INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #076720	SUPPL-23	MORPHINE SULFATE	NESHER PHARMS	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #076723	SUPPL-8	HYDROMORPHONE HYDROCHLORIDE	NOSTRUM LABS INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #076733	SUPPL-22	MORPHINE SULFATE	NESHER PHARMS	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #076758	SUPPL-17	OXYCODONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #076855	SUPPL-13	HYDROMORPHONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #076914	SUPPL-6	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	GRAVITI PHARMS	REMS	Approval
09/18/2018	FENTANYL-100 ANDA #077062	SUPPL-38	FENTANYL	MAYNE PHARMA	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #077062	SUPPL-38	FENTANYL	MAYNE PHARMA	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #077062	SUPPL-38	FENTANYL	MAYNE PHARMA	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #077062	SUPPL-38	FENTANYL	MAYNE PHARMA	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #077142	SUPPL-17	METHADONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-100 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-12 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-37 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-62 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #077154	SUPPL-20	FENTANYL	SPECGX LLC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #077184	SUPPL-15	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #077290	SUPPL-24	OXYCODONE HYDROCHLORIDE	NESHER PHARMS	REMS	Approval
09/18/2018	FENTANYL-100 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-12 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-37 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-62 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	FENTANYL-87 ANDA #077449	SUPPL-26	FENTANYL	AVEVA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077454	SUPPL-3	HYDROCODONE BITARTRATE; IBUPROFEN	ANI PHARMS	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #077471	SUPPL-12	HYDROMORPHONE HYDROCHLORIDE	GENUS	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #077712	SUPPL-24	OXYCODONE HYDROCHLORIDE	STRIDES PHARMA	REMS	Approval
09/18/2018	HYDROCODONE ANDA #077723	SUPPL-21	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723	SUPPL-21	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #077855	SUPPL-20	MORPHINE SULFATE	NESHER PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #077858	SUPPL-7	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	RISING	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078316	SUPPL-8	IBUPROFEN; OXYCODONE HYDROCHLORIDE	BARR LABS INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078394	SUPPL-15	IBUPROFEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #078761	SUPPL-13	MORPHINE SULFATE	SUN PHARM INDS LTD	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078769	SUPPL-22	IBUPROFEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #078778	SUPPL-7	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	NOSTRUM LABS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #078783	SUPPL-8	TRAMADOL HYDROCHLORIDE	STRIDES PHARMA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #079040	SUPPL-18	MORPHINE SULFATE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #079046	SUPPL-28	OXYMORPHONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #079087	SUPPL-32	OXYMORPHONE HYDROCHLORIDE	IMPAX LABS	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #080448	SUPPL-21	MEPERIDINE HYDROCHLORIDE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081249	SUPPL-11	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081250	SUPPL-11	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	REMS	Approval
09/18/2018	TYLENOL W/ CODEINE NO. 1 ANDA #085055	SUPPL-60	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	REMS	Approval
09/18/2018	TYLENOL W/ CODEINE NO. 2 ANDA #085055	SUPPL-60	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	REMS	Approval
09/18/2018	TYLENOL W/ CODEINE NO. 3 ANDA #085055	SUPPL-60	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	REMS	Approval
09/18/2018	TYLENOL W/ CODEINE NO. 4 ANDA #085055	SUPPL-60	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	REMS	Approval
09/18/2018	PERCOCET ANDA #085106	SUPPL-27	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085861	SUPPL-77	ACETAMINOPHEN; CODEINE PHOSPHATE	ACTAVIS MID ATLANTIC	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085868	SUPPL-63	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	REMS	Approval
09/18/2018	ROXICET ANDA #087003	SUPPL-41	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087006	SUPPL-33	ACETAMINOPHEN; CODEINE PHOSPHATE	WOCKHARDT BIO AG	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087006	SUPPL-34	ACETAMINOPHEN; CODEINE PHOSPHATE	WOCKHARDT BIO AG	Labeling	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087083	SUPPL-50	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #087393	SUPPL-46	METHADONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	OXYCET ANDA #087463	SUPPL-42	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087508	SUPPL-43	ACETAMINOPHEN; CODEINE PHOSPHATE	GENUS LIFESCIENCES	REMS	Approval
09/18/2018	OXYCODONE AND ASPIRIN ANDA #087794	SUPPL-27	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #087997	SUPPL-38	METHADONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #088629	SUPPL-68	ACETAMINOPHEN; CODEINE PHOSPHATE	NOSTRUM LABS INC	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #088639	SUPPL-40	MEPERIDINE HYDROCHLORIDE	BARR	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #088640	SUPPL-42	MEPERIDINE HYDROCHLORIDE	BARR	REMS	Approval
09/18/2018	MEPERIDINE HYDROCHLORIDE ANDA #088744	SUPPL-27	MEPERIDINE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ROXICET ANDA #089351	SUPPL-29	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089450	SUPPL-24	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089805	SUPPL-31	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089828	SUPPL-29	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE INTENSOL ANDA #089897	SUPPL-39	METHADONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089990	SUPPL-26	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089997	SUPPL-21	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089998	SUPPL-21	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089999	SUPPL-20	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #090065	SUPPL-9	METHADONE HYDROCHLORIDE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE AND ASPIRIN ANDA #090084	SUPPL-5	ASPIRIN; OXYCODONE HYDROCHLORIDE	ACTAVIS LABS FL INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090118	SUPPL-27	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090177	SUPPL-12	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #090404	SUPPL-8	TRAMADOL HYDROCHLORIDE	ZYDUS PHARMS USA INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090415	SUPPL-16	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ENDO OPERATIONS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #090460	SUPPL-9	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	ZYDUS PHARMS USA INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #090485	SUPPL-16	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	AMNEAL PHARMS	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090535	SUPPL-10	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #090635	SUPPL-20	METHADONE HYDROCHLORIDE	THEPHARMANETWORK LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #090659	SUPPL-18	OXYCODONE HYDROCHLORIDE	SUN PHARM INDS INC	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #090707	SUPPL-17	METHADONE HYDROCHLORIDE	VISTAPHARM LLC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090733	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090734	SUPPL-19	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #090895	SUPPL-10	OXYCODONE HYDROCHLORIDE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #090964	SUPPL-6	OXYMORPHONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #091238	SUPPL-15	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL MOLECULAR	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #091313	SUPPL-6	OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #091357	SUPPL-4	MORPHINE SULFATE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #091393	SUPPL-15	OXYCODONE HYDROCHLORIDE	AVANTHI INC	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #091443	SUPPL-9	OXYMORPHONE HYDROCHLORIDE	TEVA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #091490	SUPPL-5	OXYCODONE HYDROCHLORIDE	RHODES PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #091498	SUPPL-7	TRAMADOL HYDROCHLORIDE	CSPC OUYI PHARM CO	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #091607	SUPPL-14	TRAMADOL HYDROCHLORIDE	SUN PHARM	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #091609	SUPPL-7	TRAMADOL HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #091633	SUPPL-7	HYDROCODONE BITARTRATE; IBUPROFEN	SUN PHARM INDS INC	REMS	Approval
09/18/2018	OXYCODONE AND ASPIRIN ANDA #091670	SUPPL-2	ASPIRIN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #200343	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #200411	SUPPL-10	MORPHINE SULFATE	IMPAX LABS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #200491	SUPPL-10	TRAMADOL HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #200503	SUPPL-7	TRAMADOL HYDROCHLORIDE	LUPIN LTD	REMS	Approval
09/18/2018	NUCYNTA ER NDA #200533	SUPPL-18	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	REMS	Approval
09/18/2018	NUCYNTA ER NDA #200533	SUPPL-19	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #200534	SUPPL-7	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #200534	SUPPL-8	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #200535	SUPPL-14	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #200535	SUPPL-15	OXYCODONE HYDROCHLORIDE	GENUS LIFESCIENCES	Labeling	Approval
09/18/2018	MORPHINE SULFATE ANDA #200812	SUPPL-13	MORPHINE SULFATE	STRIDES PHARMA	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #200822	SUPPL-12	OXYMORPHONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #200824	SUPPL-17	MORPHINE SULFATE	RISING PHARMA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #201011	SUPPL-1	MORPHINE SULFATE	NOSTRUM LABS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #201013	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #201187	SUPPL-4	OXYMORPHONE HYDROCHLORIDE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #201194	SUPPL-3	OXYCODONE HYDROCHLORIDE	VISTAPHARM LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE NDA #201194	SUPPL-4	OXYCODONE HYDROCHLORIDE	VISTAPHARM LLC	Labeling	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #201278	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	RHODES PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #201384	SUPPL-12	TRAMADOL HYDROCHLORIDE	SUN PHARM	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #201447	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	MORPHINE SULFATE NDA #201517	SUPPL-12	MORPHINE SULFATE	CHARTWELL MOLECULAR	REMS	Approval
09/18/2018	MORPHINE SULFATE NDA #201517	SUPPL-13	MORPHINE SULFATE	CHARTWELL MOLECULAR	Labeling	Approval
09/18/2018	MORPHINE SULFATE ANDA #201574	SUPPL-3	MORPHINE SULFATE	PADAGIS US	REMS	Approval
09/18/2018	OPANA ER NDA #201655	SUPPL-24	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	REMS	Approval
09/18/2018	OPANA ER NDA #201655	SUPPL-25	OXYMORPHONE HYDROCHLORIDE	ENDO PHARMS	Labeling	Approval
09/18/2018	MORPHINE SULFATE ANDA #201947	SUPPL-4	MORPHINE SULFATE	VISTAPHARM	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #201952	SUPPL-9	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	MICRO LABS LTD INDIA	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #201972	SUPPL-11	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #201973	SUPPL-3	TRAMADOL HYDROCHLORIDE	IPCA LABS LTD	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #202076	SUPPL-3	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	ALKEM LABS LTD	REMS	Approval
09/18/2018	OXAYDO NDA #202080	SUPPL-9	OXYCODONE HYDROCHLORIDE	ZYLA	REMS	Approval
09/18/2018	OXAYDO NDA #202080	SUPPL-10	OXYCODONE HYDROCHLORIDE	ZYLA	Labeling	Approval
09/18/2018	FENTANYL-100 ANDA #202097	SUPPL-4	FENTANYL	KINDEVA	REMS	Approval
09/18/2018	FENTANYL-12 ANDA #202097	SUPPL-4	FENTANYL	KINDEVA	REMS	Approval
09/18/2018	FENTANYL-25 ANDA #202097	SUPPL-4	FENTANYL	KINDEVA	REMS	Approval
09/18/2018	FENTANYL-50 ANDA #202097	SUPPL-4	FENTANYL	KINDEVA	REMS	Approval
09/18/2018	FENTANYL-75 ANDA #202097	SUPPL-4	FENTANYL	KINDEVA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #202104	SUPPL-11	MORPHINE SULFATE	UPSHER SMITH LABS	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #202116	SUPPL-5	OXYCODONE HYDROCHLORIDE	ALVOGEN	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #202144	SUPPL-15	HYDROMORPHONE HYDROCHLORIDE	ACTAVIS LABS FL INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #202160	SUPPL-4	OXYCODONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202214	SUPPL-8	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TRIS PHARMA INC	REMS	Approval
09/18/2018	CODEINE SULFATE NDA #202245	SUPPL-6	CODEINE SULFATE	HIKMA	REMS	Approval
09/18/2018	CODEINE SULFATE NDA #202245	SUPPL-7	CODEINE SULFATE	HIKMA	Labeling	Approval
09/18/2018	MORPHINE SULFATE ANDA #202309	SUPPL-2	MORPHINE SULFATE	CHARTWELL MOLECULAR	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #202310	SUPPL-2	MORPHINE SULFATE	CHARTWELL MOLECULAR	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #202321	SUPPL-3	OXYMORPHONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #202348	SUPPL-6	MORPHINE SULFATE	SPECGX LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #202537	SUPPL-2	OXYCODONE HYDROCHLORIDE	VISTAPHARM	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #202662	SUPPL-5	OXYCODONE HYDROCHLORIDE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #202677	SUPPL-10	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ALVOGEN	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #202718	SUPPL-7	MORPHINE SULFATE	TEVA PHARMS USA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #202773	SUPPL-2	OXYCODONE HYDROCHLORIDE	AVANTHI INC	REMS	Approval
09/18/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #202800	SUPPL-9	ACETAMINOPHEN; CODEINE PHOSPHATE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	ZOHYDRO ER NDA #202880	SUPPL-14	HYDROCODONE BITARTRATE	RECRO GAINESVILLE	REMS	Approval
09/18/2018	ZOHYDRO ER NDA #202880	SUPPL-15	HYDROCODONE BITARTRATE	RECRO GAINESVILLE	Labeling	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202935	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #202946	SUPPL-8	OXYMORPHONE HYDROCHLORIDE	SPECGX LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202991	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	RHODES PHARMS	REMS	Approval
09/18/2018	CODEINE SULFATE ANDA #203046	SUPPL-7	CODEINE SULFATE	LANNETT CO INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #203107	SUPPL-2	OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #203208	SUPPL-4	OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ANDA #203335	SUPPL-5	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #203447	SUPPL-2	OXYCODONE HYDROCHLORIDE	ANI PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #203494	SUPPL-8	TRAMADOL HYDROCHLORIDE	AUROBINDO PHARMA LTD	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #203502	SUPPL-5	METHADONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #203518	SUPPL-4	MORPHINE SULFATE	TRIS PHARMA INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #203519	SUPPL-2	MORPHINE SULFATE	TRIS PHARMA INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ANDA #203573	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #203601	SUPPL-5	OXYMORPHONE HYDROCHLORIDE	AVANTHI INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #203602	SUPPL-7	MORPHINE SULFATE	NOVEL LABS INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #203638	SUPPL-3	OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS	REMS	Approval
09/18/2018	NUCYNTA NDA #203794	SUPPL-5	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	REMS	Approval
09/18/2018	NUCYNTA NDA #203794	SUPPL-6	TAPENTADOL HYDROCHLORIDE	COLLEGIUM PHARM INC	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #203823	SUPPL-7	OXYCODONE HYDROCHLORIDE	LANNETT CO INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #203849	SUPPL-15	MORPHINE SULFATE	ACTAVIS ELIZABETH	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #203863	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	EPIC PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204021	SUPPL-2	OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	REMS	Approval
09/18/2018	XARTEMIS XR NDA #204031	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MALLINCKRODT INC	REMS	Approval
09/18/2018	XARTEMIS XR NDA #204031	SUPPL-5	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MALLINCKRODT INC	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204037	SUPPL-7	OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204085	SUPPL-4	OXYCODONE HYDROCHLORIDE	CHARTWELL MOLECULAR	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204092	SUPPL-3	OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ANDA #204209	SUPPL-7	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	LARKEN LABS INC	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #204278	SUPPL-12	HYDROMORPHONE HYDROCHLORIDE	PADAGIS US	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #204407	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #204421	SUPPL-6	TRAMADOL HYDROCHLORIDE	AUROBINDO PHARMA LTD	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #204459	SUPPL-2	OXYMORPHONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #204575	SUPPL-2	HYDROCODONE BITARTRATE; IBUPROFEN	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204603	SUPPL-3	OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204752	SUPPL-1	OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	REMS	Approval
09/18/2018	TREZIX ANDA #204785	SUPPL-8	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	KEY THERAP	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #204979	SUPPL-4	OXYCODONE HYDROCHLORIDE	ANI PHARMS	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #205001	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #205177	SUPPL-4	OXYCODONE HYDROCHLORIDE	ANI PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #205257	SUPPL-6	TRAMADOL HYDROCHLORIDE	MYLAN	REMS	Approval
09/18/2018	LEVONORGESTREL ANDA #205329	ORIG-1	LEVONORGESTREL	XIROMED		Approval
09/18/2018	MORPHINE SULFATE ANDA #205386	SUPPL-5	MORPHINE SULFATE	DR REDDYS LABS SA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #205509	SUPPL-1	MORPHINE SULFATE	ANI PHARMS	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #205629	SUPPL-6	HYDROMORPHONE HYDROCHLORIDE	OSMOTICA PHARM US	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #205634	SUPPL-5	MORPHINE SULFATE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE ANDA #205702	SUPPL-7	TRAMADOL HYDROCHLORIDE	MACLEODS PHARMS LTD	REMS	Approval
09/18/2018	TARGINIQ NDA #205777	SUPPL-10	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	REMS	Approval
09/18/2018	TARGINIQ NDA #205777	SUPPL-11	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	Labeling	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #205814	SUPPL-2	HYDROMORPHONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206142	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206245	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #206308	SUPPL-1	MORPHINE SULFATE	RHODES PHARMS	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #206420	SUPPL-1	MORPHINE SULFATE	RHODES PHARMS	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #206456	SUPPL-3	OXYCODONE HYDROCHLORIDE	XTTRIUM LABS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206470	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ACTAVIS LABS FL INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206484	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	UPSHER SMITH LABS	REMS	Approval
09/18/2018	MORPHABOND ER NDA #206544	SUPPL-8	MORPHINE SULFATE	OHEMO LIFE	REMS	Approval
09/18/2018	MORPHABOND ER NDA #206544	SUPPL-10	MORPHINE SULFATE	OHEMO LIFE	Labeling	Approval
09/18/2018	MORPHINE SULFATE ANDA #206573	SUPPL-1	MORPHINE SULFATE	PHARM ASSOC	REMS	Approval
09/18/2018	HYSINGLA ER NDA #206627	SUPPL-7	HYDROCODONE BITARTRATE	PURDUE PHARMA LP	REMS	Approval
09/18/2018	HYSINGLA ER NDA #206627	SUPPL-8	HYDROCODONE BITARTRATE	PURDUE PHARMA LP	Labeling	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206718	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #206822	SUPPL-1	OXYCODONE HYDROCHLORIDE	PHARM ASSOC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206869	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #206885	SUPPL-10	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	MACLEODS PHARMS LTD	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #207119	SUPPL-2	OXYCODONE HYDROCHLORIDE	NUVO PHARM	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207137	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS	REMS	Approval
09/18/2018	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #207152	SUPPL-4	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	AUROBINDO PHARMA	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207171	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207172	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207333	SUPPL-3	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	LANNETT CO INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #207418	SUPPL-2	OXYCODONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207419	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207510	SUPPL-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WES PHARMA INC	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #207511	SUPPL-3	OXYCODONE HYDROCHLORIDE	WES PHARMA INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207574	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	CEROVENE INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207709	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207808	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	RHODES PHARMS	REMS	Approval
09/18/2018	BELBUCA NDA #207932	SUPPL-8	BUPRENORPHINE HYDROCHLORIDE	BDSI	REMS	Approval
09/18/2018	BELBUCA NDA #207932	SUPPL-9	BUPRENORPHINE HYDROCHLORIDE	BDSI	Labeling	Approval
09/18/2018	XTAMPZA ER NDA #208090	SUPPL-8	OXYCODONE	COLLEGIUM PHARM INC	REMS	Approval
09/18/2018	XTAMPZA ER NDA #208090	SUPPL-10	OXYCODONE	COLLEGIUM PHARM INC	Labeling	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #208305	SUPPL-2	METHADONE HYDROCHLORIDE	SUN PHARM INDUSTRIES	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #208593	SUPPL-1	OXYCODONE HYDROCHLORIDE	ABHAI LLC	REMS	Approval
09/18/2018	ARYMO ER NDA #208603	SUPPL-3	MORPHINE SULFATE	ZYLA	REMS	Approval
09/18/2018	ARYMO ER NDA #208603	SUPPL-4	MORPHINE SULFATE	ZYLA	Labeling	Approval
09/18/2018	APADAZ NDA #208653	SUPPL-2	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	ZEVRA THERAP	Labeling	Approval
09/18/2018	APADAZ NDA #208653	SUPPL-3	ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE	ZEVRA THERAP	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #208795	SUPPL-1	OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	MORPHINE SULFATE ANDA #208809	SUPPL-1	MORPHINE SULFATE	HIKMA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #208817	SUPPL-1	OXYCODONE HYDROCHLORIDE	HIKMA	REMS	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #209021	SUPPL-2	OXYCODONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209036	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209037	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #209385	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ELITE LABS INC	REMS	Approval
09/18/2018	ROXYBOND NDA #209777	SUPPL-1	OXYCODONE HYDROCHLORIDE	PROTEGA PHARMS	REMS	Approval
09/18/2018	ROXYBOND NDA #209777	SUPPL-3	OXYCODONE HYDROCHLORIDE	PROTEGA PHARMS	Labeling	Approval
09/18/2018	OXYCODONE HYDROCHLORIDE ANDA #209897	SUPPL-1	OXYCODONE HYDROCHLORIDE	WES PHARMA INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #210079	SUPPL-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NESHER PHARMS	REMS	Approval
09/18/2018	OXYMORPHONE HYDROCHLORIDE ANDA #210175	SUPPL-2	OXYMORPHONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #210176	SUPPL-2	HYDROMORPHONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #210211	SUPPL-1	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	REMS	Approval
09/18/2018	METHADONE HYDROCHLORIDE ANDA #210484	SUPPL-1	METHADONE HYDROCHLORIDE	ELITE LABS INC	REMS	Approval
09/18/2018	HYDROMORPHONE HYDROCHLORIDE ANDA #210506	SUPPL-2	HYDROMORPHONE HYDROCHLORIDE	ASCENT PHARMS INC	REMS	Approval
09/18/2018	OXYCODONE AND ACETAMINOPHEN ANDA #210644	SUPPL-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ABHAI LLC	REMS	Approval
09/18/2018	TETRACYCLINE HYDROCHLORIDE ANDA #210674	ORIG-1	TETRACYCLINE HYDROCHLORIDE	AMNEAL PHARMS NY		Approval
09/19/2018	PROPYLTHIOURACIL NDA #006188	SUPPL-26	PROPYLTHIOURACIL	ENDO OPERATIONS	Labeling	Approval
09/19/2018	CERETEC NDA #019829	SUPPL-34	TECHNETIUM TC-99M EXAMETAZIME KIT	GE HEALTHCARE	Labeling	Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #204289	ORIG-1	PALONOSETRON HYDROCHLORIDE	SAGENT PHARMS INC		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #205648	ORIG-1	PALONOSETRON HYDROCHLORIDE	QILU PHARM HAINAN		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #205870	ORIG-1	PALONOSETRON HYDROCHLORIDE	SAGENT PHARMS INC		Approval
09/19/2018	ARIPIPRAZOLE ANDA #206240	ORIG-1	ARIPIPRAZOLE	NORVIUM BIOSCIENCE		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #206396	ORIG-1	PALONOSETRON HYDROCHLORIDE	CIPLA		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #206416	ORIG-1	PALONOSETRON HYDROCHLORIDE	MYLAN INSTITUTIONAL		Approval
09/19/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206484	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	UPSHER SMITH LABS	Labeling	Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #206801	ORIG-1	PALONOSETRON HYDROCHLORIDE	FRESENIUS KABI USA		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #206802	ORIG-1	PALONOSETRON HYDROCHLORIDE	FRESENIUS KABI USA		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #207005	ORIG-1	PALONOSETRON HYDROCHLORIDE	HOSPIRA		Approval
09/19/2018	DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #209211	ORIG-1	DEXMETHYLPHENIDATE HYDROCHLORIDE	CEDIPROF INC		Approval
09/19/2018	PALONOSETRON HYDROCHLORIDE ANDA #209287	ORIG-1	PALONOSETRON HYDROCHLORIDE	CHARTWELL RX		Approval
09/20/2018	LANOXIN NDA #009330	SUPPL-33	DIGOXIN	COVIS	Labeling	Approval
09/20/2018	LANOXIN PEDIATRIC NDA #009330	SUPPL-33	DIGOXIN	COVIS	Labeling	Approval
09/20/2018	NORCO ANDA #040099	SUPPL-22	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
09/20/2018	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040118	SUPPL-18	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	SANDOZ	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040119	SUPPL-14	ACETAMINOPHEN; CODEINE PHOSPHATE	PAI HOLDINGS	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040148	SUPPL-72	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
09/20/2018	NORCO ANDA #040148	SUPPL-72	ACETAMINOPHEN; HYDROCODONE BITARTRATE	APIL	Labeling	Approval
09/20/2018	OXYCODONE AND ASPIRIN ANDA #040260	SUPPL-16	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040400	SUPPL-28	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
09/20/2018	ANEXSIA 7.5/325 ANDA #040405	SUPPL-28	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
09/20/2018	ANEXSIA 5/325 ANDA #040409	SUPPL-28	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040419	SUPPL-25	ACETAMINOPHEN; CODEINE PHOSPHATE	SPECGX LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040545	SUPPL-16	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040680	SUPPL-12	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/20/2018	BUTORPHANOL TARTRATE ANDA #075499	SUPPL-25	BUTORPHANOL TARTRATE	APOTEX	Labeling	Approval
09/20/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075735	SUPPL-14	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	LUPIN	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076023	SUPPL-18	HYDROCODONE BITARTRATE; IBUPROFEN	TEVA	Labeling	Approval
09/20/2018	OXYMORPHONE HYDROCHLORIDE ANDA #079087	SUPPL-35	OXYMORPHONE HYDROCHLORIDE	IMPAX LABS	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081249	SUPPL-10	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #081250	SUPPL-10	ACETAMINOPHEN; CODEINE PHOSPHATE	FOSUN PHARMA	Labeling	Approval
09/20/2018	TYLENOL W/ CODEINE NO. 1 ANDA #085055	SUPPL-61	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
09/20/2018	TYLENOL W/ CODEINE NO. 2 ANDA #085055	SUPPL-61	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
09/20/2018	TYLENOL W/ CODEINE NO. 3 ANDA #085055	SUPPL-61	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
09/20/2018	TYLENOL W/ CODEINE NO. 4 ANDA #085055	SUPPL-61	ACETAMINOPHEN; CODEINE PHOSPHATE	JANSSEN PHARMS	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085861	SUPPL-76	ACETAMINOPHEN; CODEINE PHOSPHATE	ACTAVIS MID ATLANTIC	Labeling	Approval
09/20/2018	OXYCET ANDA #087463	SUPPL-43	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ASPIRIN ANDA #087794	SUPPL-28	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	SUN PHARM INDUSTRIES	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090177	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090535	SUPPL-11	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SUN PHARM INDS INC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #091633	SUPPL-9	HYDROCODONE BITARTRATE; IBUPROFEN	SUN PHARM INDS INC	Labeling	Approval
09/20/2018	OXYCODONE AND ASPIRIN ANDA #091670	SUPPL-4	ASPIRIN; OXYCODONE HYDROCHLORIDE	DR REDDYS LABS SA	Labeling	Approval
09/20/2018	HERCEPTIN BLA #103792	SUPPL-5344	TRASTUZUMAB	GENENTECH		Approval
09/20/2018	PERJETA BLA #125409	SUPPL-121	PERTUZUMAB	GENENTECH		Approval
09/20/2018	KADCYLA BLA #125427	SUPPL-102	ADO-TRASTUZUMAB EMTANSINE	GENENTECH		Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #201013	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AUROLIFE PHARMA LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #201972	SUPPL-12	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AUROLIFE PHARMA LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #202677	SUPPL-11	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ALVOGEN	Labeling	Approval
09/20/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #202800	SUPPL-11	ACETAMINOPHEN; CODEINE PHOSPHATE	AUROLIFE PHARMA LLC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202935	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
09/20/2018	OXYMORPHONE HYDROCHLORIDE ANDA #202946	SUPPL-9	OXYMORPHONE HYDROCHLORIDE	SPECGX LLC	Labeling	Approval
09/20/2018	ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ANDA #204209	SUPPL-8	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	LARKEN LABS INC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #204407	SUPPL-3	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NOVEL LABS INC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #204575	SUPPL-3	HYDROCODONE BITARTRATE; IBUPROFEN	AUROLIFE PHARMA LLC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206142	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206245	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	NOVEL LABS INC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206718	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SPECGX LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207419	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ASCENT PHARMS INC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207574	SUPPL-1	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	CEROVENE INC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209036	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	Labeling	Approval
09/20/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209037	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ABHAI LLC	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #210079	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	NESHER PHARMS	Labeling	Approval
09/20/2018	OXYCODONE AND ACETAMINOPHEN ANDA #210644	SUPPL-2	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ABHAI LLC	Labeling	Approval
09/21/2018	ALEVE NDA #020204	SUPPL-59	NAPROXEN SODIUM	BAYER	Labeling	Approval
09/21/2018	STALEVO 100 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	STALEVO 125 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	STALEVO 150 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	STALEVO 200 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	STALEVO 50 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	STALEVO 75 NDA #021485	SUPPL-38	CARBIDOPA; ENTACAPONE; LEVODOPA	ORION PHARMA		Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040105	SUPPL-32	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040171	SUPPL-34	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040203	SUPPL-10	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040248	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
09/21/2018	OXYCODONE AND ASPIRIN ANDA #040255	SUPPL-28	ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE	ANI PHARMS	Labeling	Approval
09/21/2018	PERCOCET ANDA #040330	SUPPL-52	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040355	SUPPL-36	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040432	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040482	SUPPL-20	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040535	SUPPL-32	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040608	SUPPL-14	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	MIKART	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040655	SUPPL-26	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040656	SUPPL-26	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040658	SUPPL-13	ACETAMINOPHEN; HYDROCODONE BITARTRATE	CHARTWELL	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040736	SUPPL-19	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040746	SUPPL-21	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040777	SUPPL-13	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040778	SUPPL-15	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040779	SUPPL-18	ACETAMINOPHEN; CODEINE PHOSPHATE	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #040800	SUPPL-6	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040826	SUPPL-10	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS LTD	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040834	SUPPL-14	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040838	SUPPL-13	ACETAMINOPHEN; HYDROCODONE BITARTRATE	PHARM ASSOC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040846	SUPPL-12	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	Labeling	Approval
09/21/2018	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE ANDA #040860	SUPPL-4	ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE	INGENUS PHARMS NJ	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040881	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	MIKART	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #040894	SUPPL-11	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	Labeling	Approval
09/21/2018	LEVORPHANOL TARTRATE ANDA #074278	SUPPL-13	LEVORPHANOL TARTRATE	HIKMA	Labeling	Approval
09/21/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #074736	SUPPL-34	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
09/21/2018	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE ANDA #075523	SUPPL-4	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	SUN PHARM INDS LTD	Labeling	Approval
09/21/2018	BUTORPHANOL TARTRATE ANDA #075759	SUPPL-29	BUTORPHANOL TARTRATE	RISING	Labeling	Approval
09/21/2018	BUTORPHANOL TARTRATE ANDA #075824	SUPPL-12	BUTORPHANOL TARTRATE	HIKMA	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076604	SUPPL-21	HYDROCODONE BITARTRATE; IBUPROFEN	ACTAVIS LABS FL INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #076642	SUPPL-24	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	REPREXAIN ANDA #076642	SUPPL-24	HYDROCODONE BITARTRATE; IBUPROFEN	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077454	SUPPL-2	HYDROCODONE BITARTRATE; IBUPROFEN	ANI PHARMS	Labeling	Approval
09/21/2018	EFAVIRENZ ANDA #077673	ORIG-1	EFAVIRENZ	AUROBINDO PHARMA LTD		Approval
09/21/2018	HYDROCODONE ANDA #077723	SUPPL-23	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND IBUPROFEN ANDA #077723	SUPPL-23	HYDROCODONE BITARTRATE; IBUPROFEN	NOSTRUM LABS INC	Labeling	Approval
09/21/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078316	SUPPL-9	IBUPROFEN; OXYCODONE HYDROCHLORIDE	BARR LABS INC	Labeling	Approval
09/21/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078394	SUPPL-16	IBUPROFEN; OXYCODONE HYDROCHLORIDE	WATSON LABS	Labeling	Approval
09/21/2018	OXYCODONE HYDROCHLORIDE AND IBUPROFEN ANDA #078769	SUPPL-23	IBUPROFEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #078783	SUPPL-9	TRAMADOL HYDROCHLORIDE	STRIDES PHARMA	Labeling	Approval
09/21/2018	OXYMORPHONE HYDROCHLORIDE ANDA #079046	SUPPL-29	OXYMORPHONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	PERCOCET ANDA #085106	SUPPL-28	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #085868	SUPPL-64	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	Labeling	Approval
09/21/2018	ROXICET ANDA #087003	SUPPL-42	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087083	SUPPL-51	ACETAMINOPHEN; CODEINE PHOSPHATE	SUN PHARM INDS LTD	Labeling	Approval
09/21/2018	METHADONE HYDROCHLORIDE ANDA #087393	SUPPL-47	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #087508	SUPPL-44	ACETAMINOPHEN; CODEINE PHOSPHATE	GENUS LIFESCIENCES	Labeling	Approval
09/21/2018	METHADONE HYDROCHLORIDE ANDA #087997	SUPPL-39	METHADONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #088629	SUPPL-69	ACETAMINOPHEN; CODEINE PHOSPHATE	NOSTRUM LABS INC	Labeling	Approval
09/21/2018	ROXICET ANDA #089351	SUPPL-30	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089450	SUPPL-25	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089673	SUPPL-26	ACETAMINOPHEN; CODEINE PHOSPHATE	RHODES PHARMS	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089805	SUPPL-32	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089828	SUPPL-30	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089990	SUPPL-28	ACETAMINOPHEN; CODEINE PHOSPHATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089997	SUPPL-22	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089998	SUPPL-22	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #089999	SUPPL-21	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL	Labeling	Approval
09/21/2018	OXYCODONE AND ASPIRIN ANDA #090084	SUPPL-7	ASPIRIN; OXYCODONE HYDROCHLORIDE	ACTAVIS LABS FL INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090118	SUPPL-29	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SUN PHARM INDS INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #090415	SUPPL-17	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	METHADONE HYDROCHLORIDE ANDA #090707	SUPPL-18	METHADONE HYDROCHLORIDE	VISTAPHARM LLC	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090733	SUPPL-16	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #090734	SUPPL-22	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #091238	SUPPL-16	ACETAMINOPHEN; CODEINE PHOSPHATE	CHARTWELL MOLECULAR	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #091607	SUPPL-16	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #091609	SUPPL-8	TRAMADOL HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	TRULICITY BLA #125469	SUPPL-24	DULAGLUTIDE	ELI LILLY AND CO		Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #200343	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	GENUS	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #200491	SUPPL-11	TRAMADOL HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #200503	SUPPL-8	TRAMADOL HYDROCHLORIDE	LUPIN LTD	Labeling	Approval
09/21/2018	OXYMORPHONE HYDROCHLORIDE ANDA #200822	SUPPL-13	OXYMORPHONE HYDROCHLORIDE	HIKMA	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #201384	SUPPL-14	TRAMADOL HYDROCHLORIDE	SUN PHARM	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #201447	SUPPL-15	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ACTAVIS ELIZABETH	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202214	SUPPL-9	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TRIS PHARMA INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #202991	SUPPL-5	ACETAMINOPHEN; HYDROCODONE BITARTRATE	RHODES PHARMS	Labeling	Approval
09/21/2018	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ANDA #203573	SUPPL-7	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	ENDO OPERATIONS	Labeling	Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #204421	SUPPL-7	TRAMADOL HYDROCHLORIDE	AUROBINDO PHARMA LTD	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #205001	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	STRIDES PHARMA	Labeling	Approval
09/21/2018	BUSULFAN ANDA #205106	ORIG-1	BUSULFAN	ARTHUR GRP		Approval
09/21/2018	TRAMADOL HYDROCHLORIDE ANDA #205257	SUPPL-7	TRAMADOL HYDROCHLORIDE	MYLAN	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206470	SUPPL-6	ACETAMINOPHEN; HYDROCODONE BITARTRATE	ACTAVIS LABS FL INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206869	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS NY	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207137	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	AMNEAL PHARMS	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207171	SUPPL-4	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207172	SUPPL-3	ACETAMINOPHEN; HYDROCODONE BITARTRATE	LANNETT CO INC	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207333	SUPPL-4	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	LANNETT CO INC	Labeling	Approval
09/21/2018	OXYCODONE AND ACETAMINOPHEN ANDA #207574	SUPPL-5	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	CEROVENE INC	Labeling	Approval
09/21/2018	HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #210211	SUPPL-2	ACETAMINOPHEN; HYDROCODONE BITARTRATE	WES PHARMA INC	Labeling	Approval
09/21/2018	ALBENDAZOLE ANDA #210434	ORIG-1	ALBENDAZOLE	CIPLA LTD		Approval
09/24/2018	VIRAMUNE NDA #020636	SUPPL-50	NEVIRAPINE	BOEHRINGER INGELHEIM	Labeling	Approval
09/24/2018	VIRAMUNE NDA #020933	SUPPL-40	NEVIRAPINE	BOEHRINGER INGELHEIM	Labeling	Approval
09/24/2018	DOCETAXEL NDA #022234	SUPPL-11	DOCETAXEL	HOSPIRA INC	Labeling	Approval
09/24/2018	CISPLATIN ANDA #075036	SUPPL-12	CISPLATIN	HIKMA	Labeling	Approval
09/24/2018	BENAZEPRIL HYDROCHLORIDE ANDA #076402	SUPPL-20	BENAZEPRIL HYDROCHLORIDE	CHARTWELL RX	Labeling	Approval
09/24/2018	VIRAMUNE XR NDA #201152	SUPPL-13	NEVIRAPINE	BOEHRINGER INGELHEIM	Labeling	Approval
09/24/2018	DOCETAXEL NDA #202356	SUPPL-3	DOCETAXEL	PFIZER LABS	Labeling	Approval
09/24/2018	AZITHROMYCIN ANDA #207566	ORIG-1	AZITHROMYCIN	CSPC OUYI		Approval
09/24/2018	ATAZANAVIR SULFATE ANDA #208177	ORIG-1	ATAZANAVIR SULFATE	MYLAN		Approval
09/24/2018	FIASP BLA #208751	SUPPL-3	INSULIN ASPART	NOVO		Approval
09/24/2018	FIASP FLEXTOUCH BLA #208751	SUPPL-3	INSULIN ASPART	NOVO		Approval
09/24/2018	FIASP PENFILL BLA #208751	SUPPL-3	INSULIN ASPART	NOVO		Approval
09/24/2018	METAXALONE ANDA #208774	ORIG-1	METAXALONE	APPCO		Approval
09/24/2018	OLANZAPINE ANDA #209399	ORIG-1	OLANZAPINE	JIANGSU HANSOH PHARM		Approval
09/24/2018	DOXYCYCLINE HYCLATE ANDA #211012	ORIG-1	DOXYCYCLINE HYCLATE	AJANTA PHARMA LTD		Approval
09/24/2018	METFORMIN HYDROCHLORIDE ANDA #211052	ORIG-1	METFORMIN HYDROCHLORIDE	YICHANG HUMANWELL		Approval
09/24/2018	COPIKTRA NDA #211155	ORIG-1	DUVELISIB	SECURA	Type 1 - New Molecular Entity	Approval
09/24/2018	COPIKTRA NDA #211155	ORIG-2	DUVELISIB	SECURA	Efficacy	Approval
09/25/2018	SOLTAMOX NDA #021807	SUPPL-5	TAMOXIFEN CITRATE	MAYNE PHARMA COMMRCL	Efficacy	Approval
09/25/2018	BENAZEPRIL HYDROCHLORIDE ANDA #078212	SUPPL-16	BENAZEPRIL HYDROCHLORIDE	AUROBINDO PHARMA	Labeling	Approval
09/25/2018	ZYTIGA NDA #202379	SUPPL-25	ABIRATERONE ACETATE	JANSSEN BIOTECH	Labeling	Approval
09/26/2018	HUMALOG MIX 75/25 BLA #021017	SUPPL-75	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 75/25 BLA #021017	SUPPL-79	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 75/25 KWIKPEN BLA #021017	SUPPL-75	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 75/25 KWIKPEN BLA #021017	SUPPL-79	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 75/25 PEN BLA #021017	SUPPL-75	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 75/25 PEN BLA #021017	SUPPL-79	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 BLA #021018	SUPPL-70	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 BLA #021018	SUPPL-74	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 KWIKPEN BLA #021018	SUPPL-70	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 KWIKPEN BLA #021018	SUPPL-74	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 PEN BLA #021018	SUPPL-70	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	HUMALOG MIX 50/50 PEN BLA #021018	SUPPL-74	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT	LILLY		Approval
09/26/2018	OXYCONTIN NDA #022272	SUPPL-39	OXYCODONE HYDROCHLORIDE	PURDUE PHARMA LP	Labeling	Approval
09/26/2018	CORMAX ANDA #074220	SUPPL-10	CLOBETASOL PROPIONATE	HIKMA	Manufacturing (CMC)	Approval
09/26/2018	XIAFLEX BLA #125338	SUPPL-110	COLLAGENASE CLOSTRIDIUM HISTOLYTICUM	AUXILIUM PHARMS		Approval
09/26/2018	BLISOVI FE 1/20 ANDA #201584	SUPPL-4	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	LUPIN LTD	Labeling	Approval
09/26/2018	BLISOVI FE 1/20 ANDA #201584	SUPPL-6	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	LUPIN LTD	Manufacturing (CMC)	Approval
09/26/2018	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ANDA #204733	ORIG-1	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	AUROLIFE PHARMA LLC		Approval
09/26/2018	LINAGLIPTIN; METFORMIN HYDROCHLORIDE ANDA #208459	ORIG-1	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	MSN LABS PVT LTD		Tentative Approval
09/26/2018	LYNPARZA NDA #208558	SUPPL-5	OLAPARIB	ASTRAZENECA	Efficacy	Approval
09/26/2018	IBUPROFEN ANDA #210755	ORIG-1	IBUPROFEN	GUARDIAN DRUG		Approval
09/26/2018	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ANDA #211106	ORIG-1	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	ABHAI LLC		Approval
09/26/2018	AMPHETAMINE SULFATE ANDA #211139	ORIG-1	AMPHETAMINE SULFATE	AMNEAL PHARMS		Approval
09/27/2018	DAUNORUBICIN HYDROCHLORIDE NDA #050731	SUPPL-8	DAUNORUBICIN HYDROCHLORIDE	HIKMA		Approval
09/27/2018	NATPARA BLA #125511	SUPPL-14	PARATHYROID HORMONE	NPS PHARMS INC		Approval
09/27/2018	FYCOMPA NDA #202834	SUPPL-14	PERAMPANEL	CATALYST PHARMS	Efficacy	Approval
09/27/2018	FLUDEOXYGLUCOSE F18 ANDA #203603	SUPPL-7	FLUDEOXYGLUCOSE F-18	CARDINAL HEALTH 414	Manufacturing (CMC)	Approval
09/27/2018	LYNPARZA NDA #206162	SUPPL-11	OLAPARIB	ASTRAZENECA	Labeling	Approval
09/27/2018	PROMACTA KIT NDA #207027	SUPPL-6	ELTROMBOPAG OLAMINE	NOVARTIS	Labeling	Approval
09/27/2018	SYMJEPI NDA #207534	SUPPL-3	EPINEPHRINE	ADAMIS PHARMS CORP	Efficacy	Approval
09/27/2018	FYCOMPA NDA #208277	SUPPL-2	PERAMPANEL	CATALYST PHARMS	Efficacy	Approval
09/27/2018	NETSPOT NDA #208547	SUPPL-12	GALLIUM DOTATATE GA-68	AAA USA INC	Manufacturing (CMC)	Approval
09/27/2018	RANITIDINE HYDROCHLORIDE ANDA #209859	ORIG-1	RANITIDINE HYDROCHLORIDE	AJANTA PHARMA LTD		Approval
09/27/2018	VIZIMPRO NDA #211288	ORIG-1	DACOMITINIB	PFIZER	Type 1 - New Molecular Entity	Approval
09/27/2018	EMGALITY BLA #761063	ORIG-1	GALCANEZUMAB-GNLM	ELI LILLY AND CO		Approval
09/28/2018	LIPIODOL NDA #009190	SUPPL-27	ETHIODIZED OIL	GUERBET	Manufacturing (CMC)	Approval
09/28/2018	BUSULFEX NDA #020954	SUPPL-18	BUSULFAN	OTSUKA PHARM	Labeling	Approval
09/28/2018	BUSULFEX NDA #020954	SUPPL-19	BUSULFAN	OTSUKA PHARM	Labeling	Approval
09/28/2018	CEFAZOLIN SODIUM ANDA #065141	SUPPL-4	CEFAZOLIN SODIUM	SAMSON MEDCL	Labeling	Approval
09/28/2018	CEFAZOLIN SODIUM ANDA #065141	SUPPL-5	CEFAZOLIN SODIUM	SAMSON MEDCL	Labeling	Approval
09/28/2018	ENOXAPARIN SODIUM (PRESERVATIVE FREE) ANDA #078990	ORIG-1	ENOXAPARIN SODIUM	GLAND		Approval
09/28/2018	OXYMORPHONE HYDROCHLORIDE ANDA #079087	SUPPL-28	OXYMORPHONE HYDROCHLORIDE	IMPAX LABS	Labeling	Approval
09/28/2018	XOLAIR BLA #103976	SUPPL-5231	OMALIZUMAB	GENENTECH		Approval
09/28/2018	HUMIRA BLA #125057	SUPPL-408	ADALIMUMAB	ABBVIE INC		Approval
09/28/2018	MINOCYCLINE HYDROCHLORIDE ANDA #202261	ORIG-3	MINOCYCLINE HYDROCHLORIDE	AUROBINDO PHARMA LTD		Approval
09/28/2018	KYPROLIS NDA #202714	SUPPL-21	CARFILZOMIB	ONYX PHARMS AMGEN	Efficacy	Approval
09/28/2018	DESOXIMETASONE ANDA #205620	ORIG-1	DESOXIMETASONE	ZYDUS LIFESCIENCES		Approval
09/28/2018	MOXIFLOXACIN HYDROCHLORIDE ANDA #206295	ORIG-1	MOXIFLOXACIN HYDROCHLORIDE	SUNSHINE		Approval
09/28/2018	ARIKAYCE KIT NDA #207356	ORIG-1	AMIKACIN SULFATE	INSMED INC	Type 3 - New Dosage Form	Approval
09/28/2018	FLUOCINONIDE ANDA #207680	ORIG-1	FLUOCINONIDE	PAI HOLDINGS PHARM		Approval
09/28/2018	QUETIAPINE FUMARATE ANDA #209497	ORIG-1	QUETIAPINE FUMARATE	ALIGNSCIENCE PHARMA		Approval
09/28/2018	TERIFLUNOMIDE ANDA #209613	ORIG-1	TERIFLUNOMIDE	AMNEAL PHARMS CO		Approval
09/28/2018	XYOSTED (AUTOINJECTOR) NDA #209863	ORIG-1	TESTOSTERONE ENANTHATE	ANTARES PHARMA INC	Type 3 - New Dosage Form	Approval
09/28/2018	LIBTAYO BLA #761097	ORIG-1	CEMIPLIMAB-RWLC	REGENERON PHARMACEUTICALS		Approval

All Approvals and Tentative Approvals September 2018

All Approvals and Tentative Approvals
September 2018