Drugs@FDA remastered. Index of FDA-approved NDA, ANDA, BLAs.

Approvals
Date	Drug	Company
2012-01-30	OLANZAPINE 077243	BARR PHARMS
2012-01-25	POLYETHYLENE GLYCOL 3350; SODIUM SULFATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ASCORBATE; ASCORBIC ACID 090145	NOVEL LABS INC
2012-01-24	ERBITUX 125084	IMCLONE
2012-01-18	TWYNSTA 022401	BOEHRINGER INGELHEIM
2012-01-17	ALFUZOSIN HYDROCHLORIDE 090284	INVAGEN PHARMS

Tentative Approvals
Date	Drug	Company

New or Modified Indications
Date	Drug	Company

Labeling Revisions
Date	Drug	Company
2012-01-30	MARCAINE HYDROCHLORIDE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE 016964	HOSPIRA
2012-01-30	MARCAINE 018692	HOSPIRA
2012-01-30	CAMPRAL 021431	FOREST LABS
2012-01-30	LEVEMIR 021536	NOVO NORDISK INC
2012-01-30	BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE 022046	HOSPIRA
2012-01-30	BUPIVACAINE HYDROCHLORIDE 022046	HOSPIRA
2012-01-27	EQUETRO 021710	VALIDUS PHARMS INC
2012-01-27	FANAPT 022192	NOVARTIS
2012-01-26	HYDREA 016295	BRISTOL MYERS SQUIBB
2012-01-26	DROXIA 016295	BRISTOL MYERS SQUIBB
2012-01-26	ZYRTEC ALLERGY 019835	MCNEIL CONSUMER
2012-01-26	ZYRTEC HIVES RELIEF 019835	MCNEIL CONSUMER
2012-01-26	ZONEGRAN 020789	EISAI INC
2012-01-26	LUNESTA 021476	SEPRACOR
2012-01-26	TEKTURNA 021985	NOVARTIS
2012-01-26	DORIBAX 022106	ORTHO MCNEIL JANSSEN
2012-01-26	TEKTURNA HCT 022107	NOVARTIS
2012-01-26	VALTURNA 022217	NOVARTIS
2012-01-25	GABITRIL 020646	CEPHALON
2012-01-25	MULTAQ 022425	SANOFI AVENTIS US
2012-01-25	TEKAMLO 022545	NOVARTIS
2012-01-25	AMTURNIDE 200045	NOVARTIS PHARMS
2012-01-25	OXYCODONE HYDROCHLORIDE 200535	LEHIGH VALLEY
2012-01-24	VIDAZA 050794	CELGENE
2012-01-23	LUPRON 019943	ABBOTT LABS
2012-01-23	LUPRON DEPOT 020011	ABBOTT LABS
2012-01-23	MAVIK 020528	ABBOTT
2012-01-23	TARKA 020591	ABBOTT
2012-01-23	LUPRON DEPOT 020708	ABBOTT LABS
2012-01-23	MORPHINE SULFATE 022195	ROXANE
2012-01-23	MORPHINE SULFATE 022207	ROXANE
2012-01-20	EVOCLIN 050801	STIEFEL LABS INC
2012-01-20	PRILOSEC 019810	ASTRAZENECA
2012-01-20	ASTELIN 020114	MEDA PHARMS
2012-01-20	XENICAL 020766	HOFFMANN LA ROCHE
2012-01-20	NEXIUM 021153	ASTRAZENECA
2012-01-20	NEXIUM IV 021689	ASTRAZENECA
2012-01-20	CHANTIX 021928	PFIZER INC
2012-01-20	NEXIUM 021957	ASTRAZENECA
2012-01-20	PRILOSEC 022056	ASTRAZENECA
2012-01-20	NEXIUM 022101	ASTRAZENECA
2012-01-20	VIMOVO 022511	ASTRAZENECA LP
2012-01-19	LOTENSIN 019851	NOVARTIS
2012-01-19	TRIBENZOR 200175	DAIICHI SANKYO
2012-01-19	LOTENSIN HCT 020033	NOVARTIS
2012-01-19	UNIVASC 020312	UCB INC
2012-01-19	LOTREL 020364	NOVARTIS
2012-01-19	UNIRETIC 020729	UCB INC
2012-01-19	TEVETEN 020738	ABBOTT
2012-01-19	MICARDIS 020850	BOEHRINGER INGELHEIM
2012-01-19	MICARDIS HCT 021162	BOEHRINGER INGELHEIM
2012-01-19	TEVETEN HCT 021268	ABBOTT
2012-01-18	ACCUPRIL 019885	PFIZER PHARMS
2012-01-18	ACCURETIC 020125	PFIZER PHARMS
2012-01-18	ZYBAN 020711	GLAXOSMITHKLINE
2012-01-18	AVAPRO 020757	SANOFI AVENTIS US
2012-01-18	AVALIDE 020758	SANOFI AVENTIS US
2012-01-18	DIOVAN HCT 020818	NOVARTIS
2012-01-18	MICARDIS 020850	BOEHRINGER INGELHEIM
2012-01-18	MICARDIS HCT 021162	BOEHRINGER INGELHEIM
2012-01-18	DIOVAN 021283	NOVARTIS
2012-01-18	BENICAR HCT 021532	DAIICHI SANKYO
2012-01-18	FLUDEOXYGLUCOSE F18 021870	FEINSTEIN
2012-01-18	EXFORGE 021990	NOVARTIS
2012-01-18	ALTACE 022021	KING PHARMS
2012-01-18	AZOR 022100	DAIICHI SANKYO
2012-01-18	EXFORGE HCT 022314	NOVARTIS
2012-01-17	VESICARE 021518	ASTELLAS
2012-01-17	PRADAXA 022512	BOEHRINGER INGELHEIM
2012-01-17	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER 050671	BAXTER HLTHCARE
2012-01-13	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER 050796	B BRAUN
2012-01-13	ADCETRIS 125388	SEATTLE GENETICS
2012-01-13	PROVIGIL 020717	CEPHALON
2012-01-13	ENABLEX 021513	NOVARTIS
2012-01-13	NUVIGIL 021875	CEPHALON
2012-01-13	SYNERCID 050747	KING PHARMS
2012-01-13	SYNERCID 050748	KING PHARMS
2012-01-12	THALLOUS CHLORIDE TL 201 018150	MALLINCKRODT
2012-01-12	PERIOCHIP 020774	DEXCEL PHARMA
2012-01-11	SYNAREL 019886	GD SEARLE LLC
2012-01-11	PERFOROMIST 022007	DEY PHARMA
2012-01-11	MONODOX 050641	WATSON PHARMS
2012-01-09	FAZACLO ODT 021590	AZUR PHARMA INTL

Manufacturing Change or Additions
Date	Drug	Company

Supplements
Date	Drug	Company
2012-01-20	TYSABRI 125104	BIOGEN IDEC
2012-01-19	ERBITUX 125084	IMCLONE

Efficacy Supplement with Clinical Data to Supports
Date	Drug	Company

Chemistry New Strengths
Date	Drug	Company

Drug activity in the last 30 days
Date	Drug	Company
2012-01-31	GLEEVEC 021588	NOVARTIS
2012-01-30	MARCAINE HYDROCHLORIDE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE 016964	HOSPIRA
2012-01-30	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE 016964	HOSPIRA
2012-01-30	MARCAINE 018692	HOSPIRA
2012-01-30	CAMPRAL 021431	FOREST LABS
2012-01-30	LEVEMIR 021536	NOVO NORDISK INC
2012-01-30	BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE 022046	HOSPIRA
2012-01-30	BUPIVACAINE HYDROCHLORIDE 022046	HOSPIRA
2012-01-30	OLANZAPINE 077243	BARR PHARMS
2012-01-27	EQUETRO 021710	VALIDUS PHARMS INC
2012-01-27	FANAPT 022192	NOVARTIS
2012-01-26	HYDREA 016295	BRISTOL MYERS SQUIBB
2012-01-26	DROXIA 016295	BRISTOL MYERS SQUIBB
2012-01-26	ZYRTEC ALLERGY 019835	MCNEIL CONSUMER
2012-01-26	ZYRTEC HIVES RELIEF 019835	MCNEIL CONSUMER
2012-01-26	ZONEGRAN 020789	EISAI INC
2012-01-26	LUNESTA 021476	SEPRACOR
2012-01-26	TEKTURNA 021985	NOVARTIS
2012-01-26	DORIBAX 022106	ORTHO MCNEIL JANSSEN
2012-01-26	TEKTURNA HCT 022107	NOVARTIS
2012-01-26	VALTURNA 022217	NOVARTIS
2012-01-25	GABITRIL 020646	CEPHALON
2012-01-25	MULTAQ 022425	SANOFI AVENTIS US
2012-01-25	TEKAMLO 022545	NOVARTIS
2012-01-25	POLYETHYLENE GLYCOL 3350; SODIUM SULFATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ASCORBATE; ASCORBIC ACID 090145	NOVEL LABS INC
2012-01-25	AMTURNIDE 200045	NOVARTIS PHARMS
2012-01-25	OXYCODONE HYDROCHLORIDE 200535	LEHIGH VALLEY
2012-01-24	VIDAZA 050794	CELGENE
2012-01-24	ERBITUX 125084	IMCLONE
2012-01-24	ZETIA 021445	MSP SINGAPORE
2012-01-24	VYTORIN 021687	MSP SINGAPORE
2012-01-23	LUPRON 019943	ABBOTT LABS
2012-01-23	LUPRON DEPOT 020011	ABBOTT LABS
2012-01-23	MAVIK 020528	ABBOTT
2012-01-23	TARKA 020591	ABBOTT
2012-01-23	LUPRON DEPOT 020708	ABBOTT LABS
2012-01-23	VELCADE 021602	MILLENNIUM PHARMS
2012-01-23	MORPHINE SULFATE 022195	ROXANE
2012-01-23	MORPHINE SULFATE 022207	ROXANE
2012-01-20	EVOCLIN 050801	STIEFEL LABS INC
2012-01-20	PRILOSEC 019810	ASTRAZENECA
2012-01-20	ASTELIN 020114	MEDA PHARMS
2012-01-20	XENICAL 020766	HOFFMANN LA ROCHE
2012-01-20	NEXIUM 021153	ASTRAZENECA
2012-01-20	TYSABRI 125104	BIOGEN IDEC
2012-01-20	NEXIUM IV 021689	ASTRAZENECA
2012-01-20	CHANTIX 021928	PFIZER INC
2012-01-20	NEXIUM 021957	ASTRAZENECA
2012-01-20	PRILOSEC 022056	ASTRAZENECA
2012-01-20	NEXIUM 022101	ASTRAZENECA
2012-01-20	VIMOVO 022511	ASTRAZENECA LP
2012-01-19	LOTENSIN 019851	NOVARTIS
2012-01-19	TRIBENZOR 200175	DAIICHI SANKYO
2012-01-19	LOTENSIN HCT 020033	NOVARTIS
2012-01-19	UNIVASC 020312	UCB INC
2012-01-19	LOTREL 020364	NOVARTIS
2012-01-19	UNIRETIC 020729	UCB INC
2012-01-19	TEVETEN 020738	ABBOTT
2012-01-19	MICARDIS 020850	BOEHRINGER INGELHEIM
2012-01-19	MICARDIS HCT 021162	BOEHRINGER INGELHEIM
2012-01-19	TEVETEN HCT 021268	ABBOTT
2012-01-19	ERBITUX 125084	IMCLONE
2012-01-18	ACCUPRIL 019885	PFIZER PHARMS
2012-01-18	ACCURETIC 020125	PFIZER PHARMS
2012-01-18	ZYBAN 020711	GLAXOSMITHKLINE
2012-01-18	AVAPRO 020757	SANOFI AVENTIS US
2012-01-18	AVALIDE 020758	SANOFI AVENTIS US
2012-01-18	DIOVAN HCT 020818	NOVARTIS
2012-01-18	MICARDIS 020850	BOEHRINGER INGELHEIM
2012-01-18	MICARDIS HCT 021162	BOEHRINGER INGELHEIM
2012-01-18	DIOVAN 021283	NOVARTIS
2012-01-18	VIREAD 021356	GILEAD
2012-01-18	BENICAR HCT 021532	DAIICHI SANKYO
2012-01-18	FLUDEOXYGLUCOSE F18 021870	FEINSTEIN
2012-01-18	EXFORGE 021990	NOVARTIS
2012-01-18	ALTACE 022021	KING PHARMS
2012-01-18	AZOR 022100	DAIICHI SANKYO
2012-01-18	EXFORGE HCT 022314	NOVARTIS
2012-01-18	TWYNSTA 022401	BOEHRINGER INGELHEIM
2012-01-17	ALFUZOSIN HYDROCHLORIDE 090284	INVAGEN PHARMS
2012-01-17	VESICARE 021518	ASTELLAS
2012-01-17	PRADAXA 022512	BOEHRINGER INGELHEIM
2012-01-17	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER 050671	BAXTER HLTHCARE
2012-01-13	CEFAZOLIN AND DEXTROSE 050779	B BRAUN
2012-01-13	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER 050796	B BRAUN
2012-01-13	NAFTIN 019599	MERZ PHARMS
2012-01-13	ADCETRIS 125388	SEATTLE GENETICS
2012-01-13	PROVIGIL 020717	CEPHALON
2012-01-13	ENABLEX 021513	NOVARTIS
2012-01-13	NUVIGIL 021875	CEPHALON
2012-01-13	SYNERCID 050747	KING PHARMS
2012-01-13	SYNERCID 050748	KING PHARMS
2012-01-12	THALLOUS CHLORIDE TL 201 018150	MALLINCKRODT
2012-01-12	PERIOCHIP 020774	DEXCEL PHARMA
2012-01-12	VOTRIENT 022465	GLAXOSMITHKLINE
2012-01-11	SYNAREL 019886	GD SEARLE LLC
2012-01-11	PERFOROMIST 022007	DEY PHARMA
2012-01-11	MONODOX 050641	WATSON PHARMS
2012-01-09	FAZACLO ODT 021590	AZUR PHARMA INTL

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