Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077899
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/13/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/10/2014 SUPPL-9 Labeling

Label is not available on this site.

05/25/2012 SUPPL-8 Labeling

Label is not available on this site.

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075269 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210184 ZYDUS PHARMS USA INC

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075269 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210184 ZYDUS PHARMS USA INC

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076070 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210184 ZYDUS PHARMS USA INC

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