Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019478
Company: BAYER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADALAT NIFEDIPINE 10MG CAPSULE;ORAL Discontinued None No No
ADALAT NIFEDIPINE 20MG CAPSULE;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
11/27/1985 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/1997 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/1996 SUPPL-11 Labeling

Label is not available on this site.

09/22/1993 SUPPL-10 Labeling

Label is not available on this site.

01/23/1992 SUPPL-9 Labeling

Label is not available on this site.

09/13/1991 SUPPL-8 Labeling

Label is not available on this site.

09/13/1991 SUPPL-7 Labeling

Label is not available on this site.

11/21/1989 SUPPL-6 Labeling

Label is not available on this site.

08/10/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1988 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/21/1988 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1986 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/17/1986 SUPPL-1 Labeling

Label is not available on this site.

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