USFDA: New Drug Application (NDA) & Abbreviated New Drug Application ANDA Approvals September 2011

Drug Name and FDA Appl.	Active Ingredients	NDA Chem. Type *	Review Classifi- cation **	Company
PUR-WASH (NDA # 022305)	PURIFIED WATER	5	S	NIAGARA PHARMA INC
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (NDA # 202171)	LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE	4	S	MATRIX LABS LTD
LAMIVUDINE; ZIDOVUDINE (NDA # 201151)	LAMIVUDINE; ZIDOVUDINE	5	S	CIPLA LIMITED

NDA Chemical Types
Number	Meaning
1	New molecular entity (NME)
2	New ester, new salt, or other noncovalent derivative
3	New formulation
	New combination
5	New manufacturer
6	New indication
7	Drug already marketed, but without an approved NDA
8	OTC (over-the-counter) switch

Review Classification
Letter	Meaning
P	Priority review drug: A drug that appears to represent an advance over available therapy
S	Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug
O	Orphan drug

USFDA: Abbreviated New Drug Application (ANDA) Approval

Drug Name and FDA Appl.	Active Ingredients	Company	Approval Date
HALOPERIDOL (ANDA # 091637)	HALOPERIDOL LACTATE	SAGENT PHARMS	09/02/2011
HALOPERIDOL (ANDA # 200742)	HALOPERIDOL LACTATE	SAGENT PHARMS	09/02/2011
LEVETIRACETAM (ANDA # 091093)	LEVETIRACETAM	WATSON LABS FLORIDA	09/12/2011
LEVETIRACETAM (ANDA # 091261)	LEVETIRACETAM	APOTEX INC	09/12/2011
LEVETIRACETAM (ANDA # 091285)	LEVETIRACETAM	MUTUAL PHARM CO INC	09/12/2011
LEVETIRACETAM (ANDA # 091291)	LEVETIRACETAM	PAR PHARM	09/12/2011
LEVETIRACETAM (ANDA # 091399)	LEVETIRACETAM	LUPIN LTD	09/12/2011
LEVETIRACETAM (ANDA # 091430)	LEVETIRACETAM	TEVA PHARMS	09/12/2011
LEVETIRACETAM (ANDA # 091557)	LEVETIRACETAM	ACTAVIS ELIZABETH	09/12/2011
ESZOPICLONE (ANDA # 091124)	ESZOPICLONE	LUPIN LTD	09/13/2011
FELBAMATE (ANDA # 201680)	FELBAMATE	AMNEAL PHARMS	09/13/2011
SIMVASTATIN (ANDA # 090383)	SIMVASTATIN	MICRO LABS LTD	09/16/2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (ANDA # 091375)	LEVOFLOXACIN	HIKMA FARMACEUTICA	09/16/2011
ENOXAPARIN SODIUM (PRESERVATIVE FREE) (ANDA # 076684)	ENOXAPARIN SODIUM	AMPHASTAR PHARM	09/19/2011
NORETHINDRONE (ANDA # 091325)	NORETHINDRONE	LUPIN LTD	09/19/2011
NAPROXEN (ANDA # 091432)	NAPROXEN	INVAGEN PHARMS	09/19/2011
VANCOMYCIN HYDROCHLORIDE (ANDA # 091554)	VANCOMYCIN HYDROCHLORIDE	STRIDES ARCOLAB LTD	09/19/2011
RANITIDINE HYDROCHLORIDE (ANDA # 091091)	RANITIDINE HYDROCHLORIDE	SUN PHARM INDS INC	09/20/2011
GLYCOPYRROLATE (ANDA # 090963)	GLYCOPYRROLATE	HIKMA FARMACEUTICA	09/21/2011
ONDANSETRON (ANDA # 090224)	ONDANSETRON	ZENOTECH LABS LTD	09/23/2011
TAMOXIFEN CITRATE (ANDA # 090878)	TAMOXIFEN CITRATE	APOTEX	09/23/2011
DOXERCALCIFEROL (ANDA # 091433)	DOXERCALCIFEROL	ROXANE	Not Applicable
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ANDA # 078892)	ETHINYL ESTRADIOL; NORETHINDRONE	WATSON LABS	09/26/2011
LOXAPINE SUCCINATE (ANDA # 090695)	LOXAPINE SUCCINATE	LANNETT HOLDINGS INC	09/26/2011
GALANTAMINE HYDROBROMIDE (ANDA # 077781)	GALANTAMINE HYDROBROMIDE	APOTEX INC	09/27/2011
ALPRAZOLAM (ANDA # 078469)	ALPRAZOLAM	ANCHEN PHARMS	09/29/2011
LEVOFLOXACIN (ANDA # 090787)	LEVOFLOXACIN	APOTEX INC	09/29/2011
PACLITAXEL (ANDA # 091540)	PACLITAXEL	ONCO THERAPIES LTD	09/29/2011
CLINDAMYCIN (ANDA # 090108)	CLINDAMYCIN	SAGENT STRIDES	09/30/2011
CLINDAMYCIN (ANDA # 090109)	CLINDAMYCIN	SAGENT STRIDES	09/30/2011