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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
January 2013

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 July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
01/02/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #063009		 SUPPL-34 MINOCYCLINE HYDROCHLORIDE ZYDUS Labeling Approval
01/02/2013 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #076313		 SUPPL-8 OCTREOTIDE ACETATE WEST-WARD PHARMS INT Labeling Approval
01/02/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #076502		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
01/02/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #076502		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
01/02/2013 FEXOFENADINE HYDROCHLORIDE
ANDA #076502		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
01/02/2013 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #076502		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
01/02/2013 FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #076502		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Manufacturing (CMC) Approval
01/02/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #090624		 SUPPL-2 SULFAMETHOXAZOLE; TRIMETHOPRIM AUROBINDO PHARMA Manufacturing (CMC) Approval
01/03/2013 PROZAC
NDA #018936		 SUPPL-97 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
01/03/2013 PROZAC
NDA #018936		 SUPPL-98 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
01/03/2013 SARAFEM
NDA #018936		 SUPPL-97 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
01/03/2013 SARAFEM
NDA #018936		 SUPPL-98 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
01/03/2013 ALEVE
NDA #020204		 SUPPL-42 NAPROXEN SODIUM BAYER Manufacturing (CMC) Approval
01/03/2013 PROZAC WEEKLY
NDA #021235		 SUPPL-19 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
01/03/2013 PROZAC WEEKLY
NDA #021235		 SUPPL-20 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
01/03/2013 SYMBYAX
NDA #021520		 SUPPL-35 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
01/03/2013 SYMBYAX
NDA #021520		 SUPPL-36 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
01/03/2013 AZITHROMYCIN
ANDA #065265		 SUPPL-3 AZITHROMYCIN HIKMA Labeling Approval
01/03/2013 PREVIFEM
ANDA #076334		 SUPPL-17 ETHINYL ESTRADIOL; NORGESTIMATE PH HEALTH Labeling Approval
01/03/2013 TRI-PREVIFEM
ANDA #076335		 SUPPL-14 ETHINYL ESTRADIOL; NORGESTIMATE PH HEALTH Labeling Approval
01/03/2013 KETOCONAZOLE
ANDA #076942		 SUPPL-19 KETOCONAZOLE COSETTE PHARMS NC Labeling Approval
01/03/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945		 ORIG-1 ONDANSETRON HYDROCHLORIDE AVET LIFESCIENCES Approval
01/04/2013 BUPRENEX
NDA #018401		 SUPPL-17 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
01/04/2013 REBETOL
NDA #020903		 SUPPL-49 RIBAVIRIN MERCK SHARP DOHME Manufacturing (CMC) Approval
01/04/2013 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-15 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
01/04/2013 CLARITIN
NDA #021891		 SUPPL-15 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
01/04/2013 MIRALAX
NDA #022015		 SUPPL-16 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
01/04/2013 NEXTERONE
NDA #022325		 SUPPL-4 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
01/04/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077387		 SUPPL-2 ONDANSETRON HYDROCHLORIDE AM REGENT Labeling Approval
01/04/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077582		 SUPPL-3 ONDANSETRON HYDROCHLORIDE AM REGENT Labeling Approval
01/04/2013 ONDANSETRON
ANDA #079032		 SUPPL-3 ONDANSETRON AM REGENT Labeling Approval
01/04/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #079032		 SUPPL-3 ONDANSETRON HYDROCHLORIDE AM REGENT Labeling Approval
01/04/2013 ONDANSETRON HYDROCHLORIDE
ANDA #079039		 SUPPL-3 ONDANSETRON HYDROCHLORIDE LUITPOLD Labeling Approval
01/04/2013 PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
ANDA #201049		 ORIG-1 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Approval
01/04/2013 TAMSULOSIN HYDROCHLORIDE
ANDA #202010		 ORIG-1 TAMSULOSIN HYDROCHLORIDE PH HEALTH Approval
01/04/2013 LAMOTRIGINE
ANDA #202498		 ORIG-1 LAMOTRIGINE SCIEGEN PHARMS Approval
01/07/2013 NORVASC
NDA #019787		 SUPPL-53 AMLODIPINE BESYLATE VIATRIS Labeling Approval
01/07/2013 NORVASC
NDA #019787		 SUPPL-54 AMLODIPINE BESYLATE VIATRIS Labeling Approval
01/07/2013 BIOSCRUB
NDA #019822		 SUPPL-7 CHLORHEXIDINE GLUCONATE GRIFFEN Labeling Approval
01/07/2013 ALEVE
NDA #020204		 SUPPL-43 NAPROXEN SODIUM BAYER Manufacturing (CMC) Approval
01/07/2013 TYVASO
NDA #022387		 SUPPL-7 TREPROSTINIL UNITED THERAP Manufacturing (CMC) Approval
01/07/2013 EGRIFTA
BLA #022505		 SUPPL-4 TESAMORELIN ACETATE THERATECHNOLOGIES Approval
01/07/2013 SILDENAFIL CITRATE
ANDA #078380		 ORIG-1 SILDENAFIL CITRATE TEVA PHARMS Approval
01/07/2013 GEMFIBROZIL
ANDA #079072		 SUPPL-4 GEMFIBROZIL NORTHSTAR HLTHCARE Labeling Approval
01/07/2013 TORSEMIDE
ANDA #079234		 SUPPL-3 TORSEMIDE HETERO LABS LTD III Labeling Approval
01/07/2013 ADIPEX-P
ANDA #085128		 SUPPL-67 PHENTERMINE HYDROCHLORIDE TEVA Labeling Approval
01/07/2013 ADIPEX-P
ANDA #088023		 SUPPL-38 PHENTERMINE HYDROCHLORIDE TEVA Labeling Approval
01/07/2013 PHENTERMINE HYDROCHLORIDE
ANDA #090470		 SUPPL-4 PHENTERMINE HYDROCHLORIDE BARR Labeling Approval
01/07/2013 PHENTERMINE HYDROCHLORIDE
ANDA #090470		 SUPPL-5 PHENTERMINE HYDROCHLORIDE BARR Labeling Approval
01/07/2013 PHENTERMINE HYDROCHLORIDE
ANDA #090591		 SUPPL-2 PHENTERMINE HYDROCHLORIDE BARR Labeling Approval
01/07/2013 PHENTERMINE HYDROCHLORIDE
ANDA #090591		 SUPPL-3 PHENTERMINE HYDROCHLORIDE BARR Labeling Approval
01/07/2013 CEFTRIAXONE
ANDA #091068		 ORIG-1 CEFTRIAXONE SODIUM AGILA SPECLTS Approval
01/07/2013 PHENTERMINE HYDROCHLORIDE
ANDA #091451		 SUPPL-1 PHENTERMINE HYDROCHLORIDE INGENUS PHARMS LLC Labeling Approval
01/07/2013 DONEPEZIL HYDROCHLORIDE
ANDA #201001		 SUPPL-3 DONEPEZIL HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
01/08/2013 RETIN-A
NDA #017340		 SUPPL-46 TRETINOIN BAUSCH Manufacturing (CMC) Approval
01/08/2013 RETIN-A
NDA #017522		 SUPPL-36 TRETINOIN BAUSCH Manufacturing (CMC) Approval
01/08/2013 RETIN-A
NDA #019049		 SUPPL-21 TRETINOIN BAUSCH Manufacturing (CMC) Approval
01/08/2013 RENOVA
NDA #019963		 SUPPL-15 TRETINOIN VALEANT PHARMS NORTH Manufacturing (CMC) Approval
01/08/2013 RETIN-A MICRO
NDA #020475		 SUPPL-20 TRETINOIN BAUSCH Manufacturing (CMC) Approval
01/08/2013 RETIN-A-MICRO
NDA #020475		 SUPPL-20 TRETINOIN BAUSCH Manufacturing (CMC) Approval
01/08/2013 TEMODAR
NDA #021029		 SUPPL-22 TEMOZOLOMIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
01/08/2013 RENOVA
NDA #021108		 SUPPL-13 TRETINOIN VALEANT PHARMS NORTH Manufacturing (CMC) Approval
01/08/2013 CANCIDAS
NDA #021227		 SUPPL-31 CASPOFUNGIN ACETATE MERCK Labeling Approval
01/08/2013 ETOPOSIDE
ANDA #074290		 SUPPL-20 ETOPOSIDE HIKMA Labeling Approval
01/08/2013 CLADRIBINE
ANDA #075405		 SUPPL-9 CLADRIBINE HIKMA Labeling Approval
01/08/2013 ALPRAZOLAM
ANDA #077391		 SUPPL-7 ALPRAZOLAM PHARMOBEDIENT Labeling Approval
01/09/2013 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-55 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Manufacturing (CMC) Approval
01/09/2013 FREAMINE 8.5%
NDA #016822		 SUPPL-77 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE HBC 6.9%
NDA #016822		 SUPPL-77 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE II 8.5%
NDA #016822		 SUPPL-77 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE III 10%
NDA #016822		 SUPPL-77 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE III 3% W/ ELECTROLYTES
NDA #016822		 SUPPL-77 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE III 8.5%
NDA #016822		 SUPPL-77 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
01/09/2013 FREAMINE III 8.5% W/ ELECTROLYTES
NDA #016822		 SUPPL-77 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE B BRAUN Manufacturing (CMC) Approval
01/09/2013 HUMULIN R
BLA #018780		 SUPPL-139 INSULIN HUMAN LILLY Approval
01/09/2013 HUMULIN R
BLA #018780		 SUPPL-139 INSULIN RECOMBINANT HUMAN LILLY Approval
01/09/2013 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-139 INSULIN HUMAN LILLY Approval
01/09/2013 HUMULIN R PEN
BLA #018780		 SUPPL-139 INSULIN RECOMBINANT HUMAN LILLY Approval
01/09/2013 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-30 HEPARIN SODIUM B BRAUN Labeling Approval
01/09/2013 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-30 HEPARIN SODIUM B BRAUN Labeling Approval
01/09/2013 XOPENEX
NDA #020837		 SUPPL-35 LEVALBUTEROL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
01/09/2013 XOPENEX
NDA #020837		 SUPPL-37 LEVALBUTEROL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
01/09/2013 PROAIR HFA
NDA #021457		 SUPPL-28 ALBUTEROL SULFATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
01/09/2013 XOPENEX HFA
NDA #021730		 SUPPL-31 LEVALBUTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
01/09/2013 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-2 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
01/09/2013 EPIRUBICIN HYDROCHLORIDE
ANDA #065289		 SUPPL-3 EPIRUBICIN HYDROCHLORIDE HIKMA Labeling Approval
01/09/2013 EPIRUBICIN HYDROCHLORIDE
ANDA #065343		 SUPPL-3 EPIRUBICIN HYDROCHLORIDE HOSPIRA Labeling Approval
01/09/2013 FLUVOXAMINE MALEATE
ANDA #075888		 SUPPL-26 FLUVOXAMINE MALEATE AIPING PHARM INC Labeling Approval
01/09/2013 PACLITAXEL
ANDA #076131		 SUPPL-22 PACLITAXEL HOSPIRA Labeling Approval
01/09/2013 ROPINIROLE HYDROCHLORIDE
ANDA #079050		 SUPPL-3 ROPINIROLE HYDROCHLORIDE CHARTWELL RX Labeling Approval
01/09/2013 VINORELBINE TARTRATE
ANDA #091106		 SUPPL-1 VINORELBINE TARTRATE JIANGSU HANSOH PHARM Labeling Approval
01/09/2013 BROMFENAC SODIUM
ANDA #201211		 SUPPL-2 BROMFENAC SODIUM COASTAL PHARMS Labeling Approval
01/09/2013 BROMFENAC SODIUM
ANDA #202030		 ORIG-1 BROMFENAC SODIUM AMRING PHARMS Approval
01/09/2013 GELNIQUE 3%
NDA #202513		 SUPPL-3 OXYBUTYNIN ALLERGAN Labeling Approval
01/09/2013 SKYLA
NDA #203159		 ORIG-1 LEVONORGESTREL BAYER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
01/10/2013 CALAN SR
NDA #019152		 SUPPL-37 VERAPAMIL HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
01/10/2013 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-29 HEPARIN SODIUM B BRAUN Labeling Approval
01/10/2013 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-29 HEPARIN SODIUM B BRAUN Labeling Approval
01/10/2013 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-29 HEPARIN SODIUM B BRAUN Labeling Approval
01/10/2013 LIORESAL
NDA #020075		 SUPPL-25 BACLOFEN AMNEAL Manufacturing (CMC) Approval
01/10/2013 CLOLAR
NDA #021673		 SUPPL-22 CLOFARABINE GENZYME Labeling Approval
01/10/2013 LETAIRIS
NDA #022081		 SUPPL-23 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
01/10/2013 NICARDIPINE HYDROCHLORIDE
NDA #022276		 SUPPL-7 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
01/10/2013 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276		 SUPPL-7 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
01/10/2013 VIIBRYD
NDA #022567		 SUPPL-7 VILAZODONE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
01/10/2013 METAXALONE
ANDA #040445		 SUPPL-3 METAXALONE SANDOZ Manufacturing (CMC) Approval
01/10/2013 FENOFIBRATE (MICRONIZED)
ANDA #202579		 ORIG-1 FENOFIBRATE PHARMOBEDIENT Approval
01/11/2013 BENTYL
NDA #007409		 SUPPL-42 DICYCLOMINE HYDROCHLORIDE ALLERGAN Labeling Approval
01/11/2013 BENTYL
NDA #008370		 SUPPL-33 DICYCLOMINE HYDROCHLORIDE ABBVIE Labeling Approval
01/11/2013 BENTYL PRESERVATIVE FREE
NDA #008370		 SUPPL-33 DICYCLOMINE HYDROCHLORIDE ABBVIE Labeling Approval
01/11/2013 SAIZEN
BLA #019764		 SUPPL-52 SOMATROPIN EMD SERONO Approval
01/11/2013 SAIZEN
BLA #019764		 SUPPL-53 SOMATROPIN EMD SERONO Approval
01/11/2013 DURACLON
NDA #020615		 SUPPL-4 CLONIDINE HYDROCHLORIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
01/11/2013 MINIRIN
NDA #021333		 SUPPL-8 DESMOPRESSIN ACETATE FERRING Manufacturing (CMC) Approval
01/11/2013 ZETIA
NDA #021445		 SUPPL-34 EZETIMIBE ORGANON Manufacturing (CMC) Approval
01/11/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-19 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/11/2013 OXYCONTIN
NDA #022272		 SUPPL-16 OXYCODONE HYDROCHLORIDE KNOA PHARMA Labeling Approval
01/11/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077840		 SUPPL-2 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
01/14/2013 KADIAN
NDA #020616		 SUPPL-46 MORPHINE SULFATE ALLERGAN Manufacturing (CMC) Approval
01/14/2013 BROVANA
NDA #021912		 SUPPL-21 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
01/14/2013 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #201615		 ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE CHARTWELL RX Approval
01/14/2013 OPANA ER
NDA #201655		 SUPPL-4 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
01/14/2013 UCERIS
NDA #203634		 ORIG-1 BUDESONIDE SALIX Type 5 - New Formulation or New Manufacturer Approval
01/14/2013 VAZALORE
NDA #203697		 ORIG-1 ASPIRIN PLX PHARMA Type 3 - New Dosage Form Approval
01/15/2013 ADAGEN
BLA #019818		 SUPPL-46 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
01/15/2013 OVIDREL
BLA #021149		 SUPPL-29 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
01/15/2013 OVIDREL
BLA #021149		 SUPPL-31 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
01/15/2013 TRIGLIDE
NDA #021350		 SUPPL-13 FENOFIBRATE JAGOTEC Labeling Approval
01/15/2013 ACETADOTE
NDA #021539		 SUPPL-13 ACETYLCYSTEINE CUMBERLAND PHARMS Manufacturing (CMC) Approval
01/15/2013 EVAMIST
NDA #022014		 SUPPL-12 ESTRADIOL PADAGIS US Manufacturing (CMC) Approval
01/15/2013 DULERA
NDA #022518		 SUPPL-8 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
01/15/2013 CEFAZOLIN SODIUM
ANDA #062831		 SUPPL-29 CEFAZOLIN SODIUM SANDOZ Labeling Approval
01/15/2013 NAFCILLIN SODIUM
ANDA #090005		 SUPPL-4 NAFCILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
01/15/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #091469		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
01/16/2013 PERIDEX
NDA #019028		 SUPPL-20 CHLORHEXIDINE GLUCONATE SOLVENTUM Labeling Approval
01/16/2013 PERIDEX
NDA #019028		 SUPPL-22 CHLORHEXIDINE GLUCONATE SOLVENTUM Manufacturing (CMC) Approval
01/16/2013 PROSCAR
NDA #020180		 SUPPL-43 FINASTERIDE ORGANON Labeling Approval
01/16/2013 GLUCAGEN
NDA #020918		 SUPPL-38 GLUCAGON HYDROCHLORIDE NOVO NORDISK Manufacturing (CMC) Approval
01/16/2013 TERCONAZOLE
NDA #021735		 SUPPL-5 TERCONAZOLE FOUGERA PHARMS INC Manufacturing (CMC) Approval
01/16/2013 INCRELEX
BLA #021839		 SUPPL-14 MECASERMIN RECOMBINANT IPSEN INC Approval
01/16/2013 LETAIRIS
NDA #022081		 SUPPL-24 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
01/16/2013 RESTASIS
NDA #050790		 SUPPL-19 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
01/16/2013 RESTASIS MULTIDOSE
NDA #050790		 SUPPL-19 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
01/16/2013 CLINDESSE
NDA #050793		 SUPPL-17 CLINDAMYCIN PHOSPHATE PADAGIS US Manufacturing (CMC) Approval
01/16/2013 CLONIDINE HYDROCHLORIDE
ANDA #070317		 SUPPL-23 CLONIDINE HYDROCHLORIDE RISING Labeling Approval
01/16/2013 CLONIDINE HYDROCHLORIDE
ANDA #070974		 SUPPL-40 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/16/2013 CLONIDINE HYDROCHLORIDE
ANDA #070975		 SUPPL-41 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/16/2013 CLONIDINE HYDROCHLORIDE
ANDA #070976		 SUPPL-40 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/16/2013 MEGESTROL ACETATE
ANDA #075671		 SUPPL-16 MEGESTROL ACETATE STRIDES PHARMA INTL Labeling Approval
01/16/2013 MORPHINE SULFATE
ANDA #079040		 ORIG-1 MORPHINE SULFATE ACTAVIS ELIZABETH Approval
01/17/2013 ANECTINE
NDA #008453		 SUPPL-30 SUCCINYLCHOLINE CHLORIDE SANDOZ Manufacturing (CMC) Approval
01/17/2013 CAMPTOSAR
NDA #020571		 SUPPL-44 IRINOTECAN HYDROCHLORIDE PFIZER INC Manufacturing (CMC) Approval
01/17/2013 KALETRA
NDA #021226		 SUPPL-37 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
01/17/2013 KALETRA
NDA #021251		 SUPPL-45 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
01/17/2013 GONAL-F
BLA #021765		 SUPPL-18 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/17/2013 GONAL-F
BLA #021765		 SUPPL-19 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/17/2013 GONAL-F RFF
BLA #021765		 SUPPL-18 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/17/2013 GONAL-F RFF
BLA #021765		 SUPPL-19 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/17/2013 KALETRA
NDA #021906		 SUPPL-38 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
01/17/2013 EMBEDA
NDA #022321		 SUPPL-8 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Manufacturing (CMC) Approval
01/17/2013 GABLOFEN
NDA #022462		 SUPPL-4 BACLOFEN PIRAMAL CRITICAL Manufacturing (CMC) Approval
01/17/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #040840		 SUPPL-4 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
01/17/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #040841		 SUPPL-4 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
01/17/2013 HYDROXYZINE HYDROCHLORIDE
ANDA #040842		 SUPPL-4 HYDROXYZINE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
01/17/2013 CEFAZOLIN SODIUM
ANDA #065247		 SUPPL-11 CEFAZOLIN SODIUM HOSPIRA INC Labeling Approval
01/17/2013 CLONIDINE HYDROCHLORIDE
ANDA #070923		 SUPPL-31 CLONIDINE HYDROCHLORIDE TP ANDA HOLDINGS Labeling Approval
01/17/2013 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #071017		 SUPPL-63 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
01/17/2013 RAMIPRIL
ANDA #076549		 SUPPL-9 RAMIPRIL WATSON LABS Labeling Approval
01/17/2013 RAMIPRIL
ANDA #076549		 SUPPL-11 RAMIPRIL WATSON LABS Labeling Approval
01/17/2013 RAMIPRIL
ANDA #076549		 SUPPL-12 RAMIPRIL WATSON LABS Labeling Approval
01/17/2013 CLONIDINE HYDROCHLORIDE
ANDA #078895		 SUPPL-7 CLONIDINE HYDROCHLORIDE UNICHEM Labeling Approval
01/17/2013 VALACYCLOVIR HYDROCHLORIDE
ANDA #079012		 SUPPL-4 VALACYCLOVIR HYDROCHLORIDE RISING Labeling Approval
01/17/2013 CLONIDINE HYDROCHLORIDE
ANDA #091368		 SUPPL-2 CLONIDINE HYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
01/17/2013 ZECUITY
NDA #202278		 ORIG-1 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Type 3 - New Dosage Form Approval
01/17/2013 CIDOFOVIR
ANDA #202501		 SUPPL-1 CIDOFOVIR AVET LIFESCIENCES Labeling Approval
01/17/2013 FELODIPINE
ANDA #203417		 ORIG-1 FELODIPINE AUROBINDO PHARMA LTD Approval
01/18/2013 AVC
NDA #006530		 SUPPL-19 SULFANILAMIDE PHARMOBEDIENT Manufacturing (CMC) Approval
01/18/2013 SAIZEN
BLA #019764		 SUPPL-54 SOMATROPIN EMD SERONO Approval
01/18/2013 GONAL-F
BLA #020378		 SUPPL-47 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/18/2013 VISIPAQUE 270
NDA #020808		 SUPPL-20 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
01/18/2013 VISIPAQUE 320
NDA #020808		 SUPPL-20 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
01/18/2013 IDKIT:HP
NDA #021314		 SUPPL-3 CITRIC ACID; UREA C-13 MERIDIAN BIOSCIENCE Manufacturing (CMC) Approval
01/18/2013 INVANZ
NDA #021337		 SUPPL-39 ERTAPENEM SODIUM MSD SUB MERCK Manufacturing (CMC) Approval
01/18/2013 ALIMTA
NDA #021462		 SUPPL-42 PEMETREXED DISODIUM LILLY Manufacturing (CMC) Approval
01/18/2013 LIPOFEN
NDA #021612		 SUPPL-13 FENOFIBRATE CIPHER PHARMS INC Manufacturing (CMC) Approval
01/18/2013 LIPOFEN
NDA #021612		 SUPPL-14 FENOFIBRATE CIPHER PHARMS INC Manufacturing (CMC) Approval
01/18/2013 LIPOFEN
NDA #021612		 SUPPL-15 FENOFIBRATE CIPHER PHARMS INC Labeling Approval
01/18/2013 DUEXIS
NDA #022519		 SUPPL-5 FAMOTIDINE; IBUPROFEN HORIZON Manufacturing (CMC) Approval
01/18/2013 CLINDAMYCIN PHOSPHATE
ANDA #062800		 SUPPL-31 CLINDAMYCIN PHOSPHATE ALMAJECT Labeling Approval
01/18/2013 CLINDAMYCIN PHOSPHATE
ANDA #062801		 SUPPL-27 CLINDAMYCIN PHOSPHATE ALMAJECT Labeling Approval
01/18/2013 CLINDAMYCIN PHOSPHATE
ANDA #062943		 SUPPL-24 CLINDAMYCIN PHOSPHATE ALMAJECT Labeling Approval
01/18/2013 CLINDAMYCIN HYDROCHLORIDE
ANDA #063083		 SUPPL-46 CLINDAMYCIN HYDROCHLORIDE WATSON LABS Labeling Approval
01/18/2013 CEFAZOLIN SODIUM
ANDA #065345		 SUPPL-9 CEFAZOLIN SODIUM SANDOZ Labeling Approval
01/18/2013 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #091425		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Approval
01/18/2013 BOTOX
BLA #103000		 SUPPL-5251 OnabotulinumtoxinA ALLERGAN Approval
01/18/2013 BOTOX COSMETIC
BLA #103000		 SUPPL-5251 OnabotulinumtoxinA ALLERGAN Approval
01/18/2013 OXACILLIN SODIUM
ANDA #201538		 ORIG-1 OXACILLIN SODIUM EUGIA PHARMA SPECLTS Approval
01/18/2013 OXACILLIN SODIUM
ANDA #201539		 ORIG-1 OXACILLIN SODIUM EUGIA PHARMA SPECLTS Approval
01/18/2013 LAMOTRIGINE
ANDA #201791		 ORIG-1 LAMOTRIGINE PH HEALTH Approval
01/18/2013 AMYVID
NDA #202008		 SUPPL-6 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
01/18/2013 AMYVID
NDA #202008		 SUPPL-8 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
01/18/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #202978		 ORIG-1 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Approval
01/18/2013 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #202978		 ORIG-1 FEXOFENADINE HYDROCHLORIDE DR REDDYS LABS LTD Approval
01/18/2013 SUCLEAR
NDA #203595		 ORIG-1 MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE BRAINTREE LABS Type 4 - New Combination Approval
01/19/2013 METOPIRONE
NDA #012911		 SUPPL-30 METYRAPONE ESTEVE Manufacturing (CMC) Approval
01/19/2013 SAIZEN
BLA #019764		 SUPPL-56 SOMATROPIN EMD SERONO Approval
01/19/2013 SAIZEN
BLA #019764		 SUPPL-57 SOMATROPIN EMD SERONO Approval
01/19/2013 SAIZEN
BLA #019764		 SUPPL-58 SOMATROPIN EMD SERONO Approval
01/22/2013 AMPYRA
NDA #022250		 SUPPL-6 DALFAMPRIDINE MERZ Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050564		 SUPPL-53 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050564		 SUPPL-55 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '500'
NDA #050564		 SUPPL-53 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '500'
NDA #050564		 SUPPL-55 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '125'
NDA #050575		 SUPPL-40 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '125'
NDA #050575		 SUPPL-42 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050575		 SUPPL-40 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050575		 SUPPL-42 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '125'
NDA #050597		 SUPPL-47 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '125'
NDA #050597		 SUPPL-49 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050597		 SUPPL-47 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '250'
NDA #050597		 SUPPL-49 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '875'
NDA #050720		 SUPPL-26 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '875'
NDA #050720		 SUPPL-28 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '200'
NDA #050725		 SUPPL-28 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '200'
NDA #050725		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '400'
NDA #050725		 SUPPL-28 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '400'
NDA #050725		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '200'
NDA #050726		 SUPPL-22 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '200'
NDA #050726		 SUPPL-24 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '400'
NDA #050726		 SUPPL-22 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 AUGMENTIN '400'
NDA #050726		 SUPPL-24 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
01/22/2013 CEFOTETAN
ANDA #065375		 SUPPL-3 CEFOTETAN DISODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
01/22/2013 LATUDA
NDA #200603		 SUPPL-9 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Labeling Approval
01/22/2013 LATUDA
NDA #200603		 SUPPL-13 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Labeling Approval
01/23/2013 PEGANONE
NDA #010841		 SUPPL-24 ETHOTOIN RECORDATI RARE Manufacturing (CMC) Approval
01/23/2013 GONAL-F
BLA #020378		 SUPPL-51 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/23/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-24 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/23/2013 GONAL-F
BLA #021765		 SUPPL-21 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/23/2013 GONAL-F RFF
BLA #021765		 SUPPL-21 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/23/2013 EXJADE
NDA #021882		 SUPPL-15 DEFERASIROX NOVARTIS Efficacy Approval
01/23/2013 EXJADE
NDA #021882		 SUPPL-16 DEFERASIROX NOVARTIS Labeling Approval
01/23/2013 TOVIAZ
NDA #022030		 SUPPL-11 FESOTERODINE FUMARATE PFIZER Manufacturing (CMC) Approval
01/23/2013 KUVAN
NDA #022181		 SUPPL-7 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Manufacturing (CMC) Approval
01/23/2013 PYLERA
NDA #050786		 SUPPL-7 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Labeling Approval
01/23/2013 LEVONORGESTREL
ANDA #091328		 ORIG-1 LEVONORGESTREL LUPIN LTD Approval
01/23/2013 AVASTIN
BLA #125085		 SUPPL-263 BEVACIZUMAB GENENTECH Approval
01/24/2013 DILAUDID
NDA #019892		 SUPPL-19 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
01/24/2013 MENOPUR
BLA #021663		 SUPPL-15 MENOTROPINS (FSH;LH) FERRING Approval
01/24/2013 LAMISIL AT
NDA #021958		 SUPPL-4 TERBINAFINE KARO HLTHCARE Manufacturing (CMC) Approval
01/24/2013 BRILINTA
NDA #022433		 SUPPL-6 TICAGRELOR ASTRAZENECA Labeling Approval
01/24/2013 IRINOTECAN HYDROCHLORIDE
ANDA #077219		 SUPPL-2 IRINOTECAN HYDROCHLORIDE CIPLA LTD Labeling Approval
01/24/2013 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-4 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
01/24/2013 IRINOTECAN HYDROCHLORIDE
ANDA #078796		 SUPPL-4 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
01/24/2013 MUPIROCIN
ANDA #201587		 ORIG-1 MUPIROCIN CALCIUM GLENMARK PHARMS Approval
01/24/2013 LEVOFLOXACIN
ANDA #202328		 ORIG-1 LEVOFLOXACIN EUGIA PHARMA Approval
01/24/2013 LEVOFLOXACIN
ANDA #202590		 ORIG-1 LEVOFLOXACIN AVET LIFESCIENCES Approval
01/24/2013 NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
ANDA #202795		 ORIG-1 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE RISING Approval
01/25/2013 HALCION
NDA #017892		 SUPPL-44 TRIAZOLAM PFIZER Manufacturing (CMC) Approval
01/25/2013 VOLTAREN
NDA #019201		 SUPPL-43 DICLOFENAC SODIUM NOVARTIS Manufacturing (CMC) Approval
01/25/2013 EMLA
NDA #019941		 SUPPL-20 LIDOCAINE; PRILOCAINE TEVA BRANDED PHARM Manufacturing (CMC) Approval
01/25/2013 VOLTAREN-XR
NDA #020254		 SUPPL-23 DICLOFENAC SODIUM NOVARTIS Manufacturing (CMC) Approval
01/25/2013 STIMATE
NDA #020355		 SUPPL-18 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
01/25/2013 STIMATE (NEEDS NO REFRIGERATION)
NDA #020355		 SUPPL-18 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
01/25/2013 PROTONIX
NDA #020987		 SUPPL-46 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
01/25/2013 AVANDIA
NDA #021071		 SUPPL-44 ROSIGLITAZONE MALEATE WOODWARD REMS Approval
01/25/2013 ELIGARD KIT
NDA #021379		 SUPPL-22 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
01/25/2013 AVANDAMET
NDA #021410		 SUPPL-32 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE SB PHARMCO REMS Approval
01/25/2013 GLEEVEC
NDA #021588		 SUPPL-37 IMATINIB MESYLATE NOVARTIS Efficacy Approval
01/25/2013 AVANDARYL
NDA #021700		 SUPPL-15 GLIMEPIRIDE; ROSIGLITAZONE MALEATE SB PHARMCO REMS Approval
01/25/2013 MEGACE ES
NDA #021778		 SUPPL-13 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
01/25/2013 NESINA
NDA #022271		 ORIG-1 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
01/25/2013 OSENI
NDA #022426		 ORIG-1 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Type 4 - New Combination Approval
01/25/2013 DULERA
NDA #022518		 SUPPL-9 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
01/25/2013 ROSIGLITAZONE MALEATE
ANDA #076747		 ORIG-1 ROSIGLITAZONE MALEATE ANI PHARMS Approval
01/25/2013 DESMOPRESSIN ACETATE
ANDA #091280		 ORIG-1 DESMOPRESSIN ACETATE SUN PHARM INDS LTD Approval
01/25/2013 STELARA
BLA #125261		 SUPPL-91 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
01/25/2013 COMPLERA
NDA #202123		 SUPPL-3 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
01/25/2013 OXYTROL FOR WOMEN
NDA #202211		 ORIG-1 OXYBUTYNIN ABBVIE Type 8 - Partial Rx to OTC Switch Approval
01/25/2013 KAZANO
NDA #203414		 ORIG-1 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Type 4 - New Combination Approval
01/27/2013 ATORVASTATIN CALCIUM
ANDA #076477		 SUPPL-5 ATORVASTATIN CALCIUM SUN PHARM INDS LTD Labeling Approval
01/27/2013 SIMVASTATIN
ANDA #078155		 SUPPL-17 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
01/28/2013 SOLTAMOX
NDA #021807		 SUPPL-2 TAMOXIFEN CITRATE MAYNE PHARMA COMMRCL Manufacturing (CMC) Approval
01/28/2013 TYZEKA
NDA #022011		 SUPPL-10 TELBIVUDINE NOVARTIS Efficacy Approval
01/28/2013 TYZEKA
NDA #022011		 SUPPL-13 TELBIVUDINE NOVARTIS Efficacy Approval
01/28/2013 FIRAZYR
NDA #022150		 SUPPL-3 ICATIBANT ACETATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
01/28/2013 TYZEKA
NDA #022154		 SUPPL-10 TELBIVUDINE NOVARTIS Efficacy Approval
01/28/2013 TRILIPIX
NDA #022224		 SUPPL-9 CHOLINE FENOFIBRATE ABBVIE Manufacturing (CMC) Approval
01/28/2013 PROGRAF
NDA #050708		 SUPPL-42 TACROLIMUS ASTELLAS Manufacturing (CMC) Approval
01/28/2013 DIAZEPAM
ANDA #071307		 SUPPL-29 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
01/28/2013 DIAZEPAM
ANDA #071321		 SUPPL-31 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
01/28/2013 DIAZEPAM
ANDA #071322		 SUPPL-31 DIAZEPAM IVAX SUB TEVA PHARMS Labeling Approval
01/28/2013 BETAMETHASONE DIPROPIONATE
ANDA #072538		 SUPPL-7 BETAMETHASONE DIPROPIONATE PADAGIS US Labeling Approval
01/28/2013 FLURBIPROFEN SODIUM
ANDA #074447		 SUPPL-23 FLURBIPROFEN SODIUM BAUSCH AND LOMB Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #074507		 SUPPL-53 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #076568		 SUPPL-25 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #076569		 SUPPL-21 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 CLONAZEPAM
ANDA #077194		 SUPPL-3 CLONAZEPAM BARR Labeling Approval
01/28/2013 CLONAZEPAM
ANDA #077194		 SUPPL-5 CLONAZEPAM BARR Labeling Approval
01/28/2013 GALANTAMINE HYDROBROMIDE
ANDA #077605		 SUPPL-5 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
01/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732		 SUPPL-5 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM HIKMA Labeling Approval
01/28/2013 ALBUTEROL SULFATE
ANDA #077839		 SUPPL-13 ALBUTEROL SULFATE RITEDOSE CORP Labeling Approval
01/28/2013 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-16 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
01/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-7 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
01/28/2013 ALPRAZOLAM
ANDA #078449		 SUPPL-3 ALPRAZOLAM APOTEX INC Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #078697		 SUPPL-9 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #078699		 SUPPL-9 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #079038		 SUPPL-8 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #079044		 SUPPL-8 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #079216		 SUPPL-10 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 NICOTINE POLACRILEX
ANDA #079219		 SUPPL-10 NICOTINE POLACRILEX P AND L Labeling Approval
01/28/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #088467		 SUPPL-40 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
01/28/2013 MONTELUKAST SODIUM
ANDA #090984		 SUPPL-2 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
01/28/2013 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-4 MONTELUKAST SODIUM AIPING PHARM INC Labeling Approval
01/28/2013 LOSARTAN POTASSIUM
ANDA #091590		 SUPPL-2 LOSARTAN POTASSIUM MYLAN Labeling Approval
01/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-5 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
01/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-7 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
01/28/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091652		 SUPPL-3 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MYLAN Labeling Approval
01/28/2013 MONTELUKAST SODIUM
ANDA #201515		 SUPPL-2 MONTELUKAST SODIUM TORRENT PHARMS LTD Labeling Approval
01/28/2013 LOSARTAN POTASSIUM
ANDA #202230		 SUPPL-1 LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
01/29/2013 MONISTAT 7
NDA #017450		 SUPPL-62 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
01/29/2013 MONISTAT 3
NDA #020827		 SUPPL-20 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
01/29/2013 TAMIFLU
NDA #021087		 SUPPL-61 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
01/29/2013 CETROTIDE
NDA #021197		 SUPPL-12 CETRORELIX ACETATE EMD SERONO INC Manufacturing (CMC) Approval
01/29/2013 TAMIFLU
NDA #021246		 SUPPL-44 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
01/29/2013 MONISTAT 3 COMBINATION PACK
NDA #021261		 SUPPL-13 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
01/29/2013 MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261		 SUPPL-13 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
01/29/2013 MULTIHANCE
NDA #021357		 SUPPL-12 GADOBENATE DIMEGLUMINE BRACCO Manufacturing (CMC) Approval
01/29/2013 MULTIHANCE MULTIPACK
NDA #021358		 SUPPL-11 GADOBENATE DIMEGLUMINE BRACCO Manufacturing (CMC) Approval
01/29/2013 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-17 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
01/29/2013 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-18 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
01/29/2013 LOVASTATIN
ANDA #075451		 SUPPL-20 LOVASTATIN AUROBINDO PHARMA USA Labeling Approval
01/29/2013 LOVASTATIN
ANDA #075551		 SUPPL-23 LOVASTATIN TEVA Labeling Approval
01/29/2013 FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
ANDA #076653		 SUPPL-13 FLUCONAZOLE DR REDDYS Labeling Approval
01/29/2013 SIMVASTATIN
ANDA #077752		 SUPPL-19 SIMVASTATIN RISING Labeling Approval
01/29/2013 SERTRALINE HYDROCHLORIDE
ANDA #078861		 SUPPL-4 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
01/29/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #088468		 SUPPL-38 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
01/29/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #089097		 SUPPL-34 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
01/29/2013 HYDRALAZINE HYDROCHLORIDE
ANDA #089098		 SUPPL-33 HYDRALAZINE HYDROCHLORIDE PLIVA Labeling Approval
01/29/2013 KYNAMRO
NDA #203568		 ORIG-1 MIPOMERSEN SODIUM KASTLE THERAPS LLC Type 1 - New Molecular Entity Approval
01/30/2013 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-44 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 CIPRO
NDA #019537		 SUPPL-81 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
01/30/2013 CIPRO
NDA #019847		 SUPPL-53 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
01/30/2013 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-60 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Labeling Approval
01/30/2013 HUMALOG
BLA #020563		 SUPPL-127 INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-127 INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG PEN
BLA #020563		 SUPPL-127 INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-127 INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 CIPRO
NDA #020780		 SUPPL-39 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
01/30/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-82 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-82 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-82 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG MIX 50/50
BLA #021018		 SUPPL-77 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-77 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-77 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
01/30/2013 CIPRO XR
NDA #021473		 SUPPL-34 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
01/30/2013 REYATAZ
NDA #021567		 SUPPL-31 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
01/30/2013 TRI-ESTARYLLA
ANDA #090793		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Approval
01/30/2013 ESTARYLLA
ANDA #090794		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Approval
01/30/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091264		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Labeling Approval
01/30/2013 TROSPIUM CHLORIDE
ANDA #091513		 SUPPL-2 TROSPIUM CHLORIDE APOTEX Labeling Approval
01/30/2013 OXYMORPHONE HYDROCHLORIDE
ANDA #203601		 ORIG-1 OXYMORPHONE HYDROCHLORIDE AVANTHI INC Approval
01/31/2013 SOMA COMPOUND
NDA #012365		 SUPPL-39 ASPIRIN; CARISOPRODOL MEDA PHARMS Labeling Approval
01/31/2013 SOMA COMPOUND W/ CODEINE
NDA #012366		 SUPPL-33 ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE MEDA PHARMS Labeling Approval
01/31/2013 SAIZEN
BLA #019764		 SUPPL-64 SOMATROPIN EMD SERONO Approval
01/31/2013 GONAL-F
BLA #020378		 SUPPL-52 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/31/2013 SEROSTIM
BLA #020604		 SUPPL-67 SOMATROPIN EMD SERONO Approval
01/31/2013 SEROSTIM LQ
BLA #020604		 SUPPL-67 SOMATROPIN EMD SERONO Approval
01/31/2013 YASMIN
NDA #021098		 SUPPL-20 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
01/31/2013 OVIDREL
BLA #021149		 SUPPL-30 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
01/31/2013 OVIDREL
BLA #021149		 SUPPL-33 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
01/31/2013 YAZ
NDA #021676		 SUPPL-13 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
01/31/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-25 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/31/2013 GONAL-F
BLA #021765		 SUPPL-22 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/31/2013 GONAL-F RFF
BLA #021765		 SUPPL-22 FOLLITROPIN ALFA/BETA EMD SERONO Approval
01/31/2013 FANAPT
NDA #022192		 SUPPL-7 ILOPERIDONE VANDA PHARMS INC Labeling Approval
01/31/2013 LATISSE
NDA #022369		 SUPPL-6 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
01/31/2013 XARELTO
NDA #022406		 SUPPL-6 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
01/31/2013 GRALISE
NDA #022544		 SUPPL-13 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
01/31/2013 METHYLERGONOVINE MALEATE
ANDA #040889		 SUPPL-1 METHYLERGONOVINE MALEATE BRECKENRIDGE Labeling Approval
01/31/2013 DEMECLOCYCLINE HYDROCHLORIDE
ANDA #065171		 SUPPL-4 DEMECLOCYCLINE HYDROCHLORIDE BARR Labeling Approval
01/31/2013 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #075256		 SUPPL-29 DESOGESTREL; ETHINYL ESTRADIOL DURAMED PHARMS BARR Labeling Approval
01/31/2013 LEUPROLIDE ACETATE
ANDA #075471		 SUPPL-26 LEUPROLIDE ACETATE MEITHEAL Labeling Approval
01/31/2013 SPRINTEC
ANDA #075804		 SUPPL-25 ETHINYL ESTRADIOL; NORGESTIMATE BARR Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076119		 SUPPL-22 MIRTAZAPINE TEVA Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076119		 SUPPL-23 MIRTAZAPINE TEVA Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076901		 SUPPL-7 MIRTAZAPINE IMPAX LABS INC Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076901		 SUPPL-11 MIRTAZAPINE IMPAX LABS INC Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076921		 SUPPL-23 MIRTAZAPINE AUROBINDO Labeling Approval
01/31/2013 MIRTAZAPINE
ANDA #076921		 SUPPL-24 MIRTAZAPINE AUROBINDO Labeling Approval
01/31/2013 OCTREOTIDE ACETATE
ANDA #077372		 SUPPL-6 OCTREOTIDE ACETATE SUN PHARM INDS Labeling Approval
01/31/2013 OCTREOTIDE ACETATE
ANDA #077373		 SUPPL-3 OCTREOTIDE ACETATE SUN PHARM INDS Labeling Approval
01/31/2013 PAROXETINE HYDROCHLORIDE
ANDA #077395		 SUPPL-9 PAROXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
01/31/2013 ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #077559		 SUPPL-4 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE CIPLA Labeling Approval
01/31/2013 CABERGOLINE
ANDA #078035		 SUPPL-5 CABERGOLINE ACTAVIS LABS FL INC Labeling Approval
01/31/2013 ENOXAPARIN SODIUM
ANDA #078660		 SUPPL-2 ENOXAPARIN SODIUM SANDOZ INC Labeling Approval
01/31/2013 POLYETHYLENE GLYCOL 3350
ANDA #079214		 ORIG-1 POLYETHYLENE GLYCOL 3350 STRIDES PHARMA INTL Approval
01/31/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090362		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM Approval
01/31/2013 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810		 SUPPL-2 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
01/31/2013 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #090810		 SUPPL-3 HEPARIN SODIUM SAGENT PHARMS Labeling Approval
01/31/2013 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #091281		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE TWI PHARMS INC Approval
01/31/2013 BUPROPION HYDROCHLORIDE
ANDA #091459		 SUPPL-2 BUPROPION HYDROCHLORIDE PH HEALTH Labeling Approval
01/31/2013 LOSARTAN POTASSIUM
ANDA #091541		 SUPPL-1 LOSARTAN POTASSIUM MICRO LABS Labeling Approval
01/31/2013 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #091674		 SUPPL-2 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Labeling Approval
01/31/2013 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-2 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
01/31/2013 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-4 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
01/31/2013 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-2 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
01/31/2013 VASCEPA
NDA #202057		 SUPPL-1 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
01/31/2013 MONTELUKAST SODIUM
ANDA #202906		 SUPPL-2 MONTELUKAST SODIUM DR REDDYS LABS LTD Labeling Approval
01/31/2013 TESTOSTERONE
NDA #203098		 ORIG-1 TESTOSTERONE PERRIGO ISRAEL Type 3 - New Dosage Form Approval
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