Drugs@FDA: FDA-Approved Drugs

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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 Discontinued None No No
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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.

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