Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016099
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROMID-S CLOFIBRATE 500MG 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
02/08/1967 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/07/1998 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1996 SUPPL-60 Labeling

Label is not available on this site.

03/24/1995 SUPPL-59 Labeling

Label is not available on this site.

04/19/1994 SUPPL-58 Labeling

Label is not available on this site.

07/27/1994 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1991 SUPPL-56 Labeling

Label is not available on this site.

03/11/1994 SUPPL-55 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/26/1989 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

07/15/1987 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/25/1990 SUPPL-52 Labeling

Label is not available on this site.

11/19/1986 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1983 SUPPL-46 Unspecified

Label is not available on this site.

08/23/1978 SUPPL-29 Labeling

Label is not available on this site.

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