Tuesday 7 February 2012

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




Drug Name
and

FDA Appl.
PURIFIED WATER
5  
NIAGARA PHARMA INC
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
4  
MATRIX LABS LTD
LAMIVUDINE; ZIDOVUDINE
5  
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 LACTATE
SAGENT PHARMS
09/02/2011  
HALOPERIDOL LACTATE
SAGENT PHARMS
09/02/2011  
LEVETIRACETAM
WATSON LABS FLORIDA
09/12/2011  
LEVETIRACETAM
APOTEX INC
09/12/2011  
LEVETIRACETAM
MUTUAL PHARM CO INC
09/12/2011  
LEVETIRACETAM
PAR PHARM
09/12/2011  
LEVETIRACETAM
LUPIN LTD
09/12/2011  
LEVETIRACETAM
TEVA PHARMS
09/12/2011  
LEVETIRACETAM
ACTAVIS ELIZABETH
09/12/2011  
ESZOPICLONE
LUPIN LTD
09/13/2011  
FELBAMATE
AMNEAL PHARMS
09/13/2011  
SIMVASTATIN
MICRO LABS LTD
09/16/2011  
LEVOFLOXACIN
HIKMA FARMACEUTICA
09/16/2011  
ENOXAPARIN SODIUM
AMPHASTAR PHARM
09/19/2011  
NORETHINDRONE
LUPIN LTD
09/19/2011  
NAPROXEN
INVAGEN PHARMS
09/19/2011  
VANCOMYCIN HYDROCHLORIDE
STRIDES ARCOLAB LTD
09/19/2011  
RANITIDINE HYDROCHLORIDE
SUN PHARM INDS INC
09/20/2011  
GLYCOPYRROLATE
HIKMA FARMACEUTICA
09/21/2011  
ONDANSETRON
ZENOTECH LABS LTD
09/23/2011  
TAMOXIFEN CITRATE
APOTEX
09/23/2011  
DOXERCALCIFEROL
ROXANE
Not Applicable 
ETHINYL ESTRADIOL; NORETHINDRONE
WATSON LABS
09/26/2011  
LOXAPINE SUCCINATE
LANNETT HOLDINGS INC
09/26/2011  
GALANTAMINE HYDROBROMIDE
APOTEX INC
09/27/2011  
ALPRAZOLAM
ANCHEN PHARMS
09/29/2011  
LEVOFLOXACIN
APOTEX INC
09/29/2011  
PACLITAXEL
ONCO THERAPIES LTD
09/29/2011  
CLINDAMYCIN
SAGENT STRIDES
09/30/2011  
CLINDAMYCIN
SAGENT STRIDES
09/30/2011  

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