Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090649
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 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
06/21/2010 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
02/03/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/16/2013 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

10/29/2012 SUPPL-5 Labeling

Label is not available on this site.

07/29/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090649 MYLAN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090649 MYLAN
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090649 MYLAN
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

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