KETOTIFEN FUMARATE
(ANDA # 077200)

000

KETOTIFEN FUMARATE

ALCON

Approval

09/02/2008

RANITIDINE
(ANDA # 078312)

000

RANITIDINE HYDROCHLORIDE

AMNEAL PHARMS

Approval

09/02/2008

CLOTRIMAZOLE
(ANDA # 078338)

000

CLOTRIMAZOLE

NYCOMED US

Approval

09/02/2008

RAMIPRIL
(ANDA # 078832)

000

RAMIPRIL

ZYDUS PHARMS USA

Approval

09/02/2008

STAVUDINE
(ANDA # 077672)

000

STAVUDINE

AUROBINDO

Tentative Approval

09/03/2008

ABACAVIR SULFATE; LAMIVUDINE
(ANDA # 090159)

000

ABACAVIR SULFATE; LAMIVUDINE

AUROBINDO PHARMA

Tentative Approval

09/03/2008

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
(ANDA # 078446)

000

POTASSIUM CHLORIDE; SODIUM CHLORIDE

HOSPIRA

Approval

09/10/2008

ALENDRONATE SODIUM
(ANDA # 090022)

000

ALENDRONATE SODIUM

SUN PHARM INDS

Approval

09/10/2008

GALANTAMINE HYDROBROMIDE
(ANDA # 077593)

000

GALANTAMINE HYDROBROMIDE

DR REDDYS LABS LTD

Approval

09/11/2008

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
(NDA # 022141)

000

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

MATRIX LABS

Tentative Approval

09/12/2008

SANCUSO
(NDA # 022198)

000

GRANISETRON

STRAKAN INTL

Approval

09/12/2008

KEPPRA XR
(NDA # 022285)

000

LEVETIRACETAM

UCB INC

Approval

09/12/2008

ABACAVIR SULFATE
(NDA # 022293)

000

ABACAVIR SULFATE

AUROBINDO PHARMA

Tentative Approval

09/12/2008

HYDRALAZINE HYDROCHLORIDE
(ANDA # 040901)

000

HYDRALAZINE HYDROCHLORIDE

HETERO DRUGS LTD

Approval

09/12/2008

RISPERIDONE
(ANDA # 076288)

000

RISPERIDONE

MYLAN

Approval

09/15/2008

RISPERIDONE
(ANDA # 077953)

000

RISPERIDONE

APOTEX INC

Approval

09/15/2008

GALANTAMINE HYDROBROMIDE
(ANDA # 078189)

000

GALANTAMINE HYDROBROMIDE

BARR

Approval

09/15/2008

PROTRIPTYLINE HYDROCHLORIDE
(ANDA # 078913)

000

PROTRIPTYLINE HYDROCHLORIDE

ROXANE

Approval

09/16/2008

AMIODARONE HYDROCHLORIDE
(ANDA # 079029)

000

AMIODARONE HYDROCHLORIDE

ZYDUS PHARMS USA INC

Approval

09/16/2008

ZIPRASIDONE HYDROCHLORIDE
(ANDA # 077562)

000

ZIPRASIDONE HYDROCHLORIDE

SANDOZ

Tentative Approval

09/17/2008

EPIRUBICIN HYDROCHLORIDE
(ANDA # 065445)

000

EPIRUBICIN HYDROCHLORIDE

ACTAVIS TOTOWA

Approval

09/18/2008

CARBIDOPA AND LEVODOPA
(ANDA # 078893)

000

CARBIDOPA; LEVODOPA

MYLAN

Approval

09/18/2008

ADREVIEW
(NDA # 022290)

000

IOBENGUANE I 123

GE HEALTHCARE

Approval

09/19/2008

CARBOPLATIN
(ANDA # 077926)

000

CARBOPLATIN

SUN PHARM INDS

Approval

09/19/2008

TECHNETIUM TC-99 SESTAMIBI
(ANDA # 078098)

000

TECHNETIUM TC-99M SESTAMIBI KIT

MALLINCKRODT

Approval

09/22/2008

AMLODIPINE BESYLATE
(ANDA # 078573)

000

AMLODIPINE BESYLATE

TORRENT PHARMS

Approval

09/22/2008

BETAMETHASONE DIPROPIONATE
(ANDA # 078930)

000

BETAMETHASONE DIPROPIONATE

GLENMARK GENERICS

Approval

09/23/2008

HYDROXYZINE HYDROCHLORIDE
(ANDA # 040808)

000

HYDROXYZINE HYDROCHLORIDE

AMNEAL PHARM

Approval

09/24/2008

NABUMETONE
(ANDA # 078420)

000

NABUMETONE

DR REDDYS LABS LTD

Approval

09/24/2008

DIDANOSINE
(ANDA # 090094)

000

DIDANOSINE

AUROBINDO PHARMA

Approval

09/24/2008

ALPRAZOLAM
(ANDA # 078491)

000

ALPRAZOLAM

VINTAGE

Approval

09/25/2008

ALFUZOSIN HYDROCHLORIDE
(ANDA # 079014)

000

ALFUZOSIN HYDROCHLORDE

MYLAN PHARMA

Tentative Approval

09/25/2008

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
(ANDA # 090096)

000

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

PADDOCK

Approval

09/25/2008

GLEEVEC
(NDA # 021588)

024

IMATINIB MESYLATE

NOVARTIS

Accelerated Approval

09/26/2008

PROMETHAZINE HYDROCHLORIDE
(ANDA # 040785)

000

PROMETHAZINE HYDROCHLORIDE

WOCKHARDT

Approval

09/26/2008

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
(ANDA # 077858)

000

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

ALPHAPHARM

Approval

09/26/2008

CYCLOBENZAPRINE HYDROCHLORIDE
(ANDA # 078643)

000

CYCLOBENZAPRINE HYDROCHLORIDE

AUROBINDO PHARMA

Approval

09/26/2008