Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016936
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMULEN 1/50-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None No No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
12/08/1970 ORIG-1 Approval Type 3 - New Dosage Form 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
12/27/1996 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/20/1994 SUPPL-40 Labeling

Label is not available on this site.

04/28/1993 SUPPL-39 Labeling

Label is not available on this site.

12/16/1991 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1988 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1991 SUPPL-30 Labeling

Label is not available on this site.

10/23/1986 SUPPL-28 Labeling

Label is not available on this site.

06/10/1986 SUPPL-27 Labeling

Label is not available on this site.

03/13/1986 SUPPL-26 Labeling

Label is not available on this site.

06/05/1985 SUPPL-25 Labeling

Label is not available on this site.

04/05/1985 SUPPL-24 Labeling

Label is not available on this site.

02/12/1985 SUPPL-23 Labeling

Label is not available on this site.

09/18/1984 SUPPL-22 Labeling

Label is not available on this site.

03/06/1984 SUPPL-20 Labeling

Label is not available on this site.

03/03/1981 SUPPL-15 Labeling

Label is not available on this site.

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