Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 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
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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English