Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072579
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 10MG 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-36 Labeling-Package Insert

Label is not available on this site.

12/11/2014 SUPPL-35 Labeling

Label is not available on this site.

12/13/2011 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

08/04/2004 SUPPL-25 Labeling

Label is not available on this site.

01/06/2003 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/2002 SUPPL-19 Labeling

Label is not available on this site.

08/22/2001 SUPPL-17 Labeling

Label is not available on this site.

11/02/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1998 SUPPL-14 Labeling

Label is not available on this site.

10/01/1997 SUPPL-13 Labeling

Label is not available on this site.

10/18/1996 SUPPL-12 Labeling

Label is not available on this site.

08/28/1996 SUPPL-11 Labeling

Label is not available on this site.

04/22/1996 SUPPL-10 Labeling

Label is not available on this site.

01/18/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/10/1992 SUPPL-7 Labeling

Label is not available on this site.

07/14/1992 SUPPL-6 Labeling

Label is not available on this site.

03/24/1992 SUPPL-5 Labeling

Label is not available on this site.

02/11/1992 SUPPL-4 Labeling

Label is not available on this site.

03/18/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/12/1992 SUPPL-2 Labeling

Label is not available on this site.

NIFEDIPINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072579 ACTAVIS ELIZABETH
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 202644 HERITAGE PHARMA
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072781 INTERGEL PHARM
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 073250 LEADING PHARMA LLC
PROCARDIA NIFEDIPINE 10MG CAPSULE;ORAL Prescription Yes AB 018482 PFIZER

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