Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016927
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMULEN 1/50-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.05MG;1MG TABLET;ORAL-21 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
04/24/1970 ORIG-1 Approval Type 4 - New Combination 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
09/02/1999 SUPPL-62 Labeling

Label is not available on this site.

04/20/1994 SUPPL-61 Labeling

Label is not available on this site.

04/28/1993 SUPPL-60 Labeling

Label is not available on this site.

12/16/1991 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-58 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1988 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1991 SUPPL-51 Labeling

Label is not available on this site.

10/23/1986 SUPPL-49 Labeling

Label is not available on this site.

06/10/1986 SUPPL-48 Labeling

Label is not available on this site.

03/13/1986 SUPPL-47 Labeling

Label is not available on this site.

06/05/1985 SUPPL-46 Labeling

Label is not available on this site.

04/05/1985 SUPPL-45 Labeling

Label is not available on this site.

02/12/1985 SUPPL-44 Labeling

Label is not available on this site.

09/18/1984 SUPPL-43 Labeling

Label is not available on this site.

03/06/1984 SUPPL-41 Labeling

Label is not available on this site.

06/03/1983 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1983 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1982 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1981 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

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