Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072556
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription AB 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
04/28/1989 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
04/12/2016 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

12/11/2014 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/13/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

02/08/2007 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/2004 SUPPL-26 Labeling

Label is not available on this site.

01/06/2003 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/2002 SUPPL-20 Labeling

Label is not available on this site.

08/22/2001 SUPPL-18 Labeling

Label is not available on this site.

11/02/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1998 SUPPL-16 Labeling

Label is not available on this site.

10/01/1997 SUPPL-15 Labeling

Label is not available on this site.

10/18/1996 SUPPL-14 Labeling

Label is not available on this site.

08/28/1996 SUPPL-13 Labeling

Label is not available on this site.

04/22/1996 SUPPL-12 Labeling

Label is not available on this site.

01/18/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/10/1992 SUPPL-9 Labeling

Label is not available on this site.

07/14/1992 SUPPL-8 Labeling

Label is not available on this site.

03/24/1992 SUPPL-7 Labeling

Label is not available on this site.

02/11/1992 SUPPL-6 Labeling

Label is not available on this site.

01/22/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/22/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/28/1990 SUPPL-2 Labeling

Label is not available on this site.

NIFEDIPINE

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 072556 ACTAVIS ELIZABETH
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 202644 HERITAGE PHARMA
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 074045 LEADING PHARMA LLC

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