Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018160
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMULEN 1/35-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None No No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
12/30/1981 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-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/1999 SUPPL-30 Labeling

Label is not available on this site.

04/20/1994 SUPPL-29 Labeling

Label is not available on this site.

04/28/1993 SUPPL-28 Labeling

Label is not available on this site.

12/16/1991 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1991 SUPPL-19 Labeling

Label is not available on this site.

10/23/1986 SUPPL-17 Labeling

Label is not available on this site.

06/10/1986 SUPPL-16 Labeling

Label is not available on this site.

03/13/1986 SUPPL-15 Labeling

Label is not available on this site.

06/03/1985 SUPPL-14 Labeling

Label is not available on this site.

09/18/1985 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/05/1985 SUPPL-12 Labeling

Label is not available on this site.

02/12/1985 SUPPL-11 Labeling

Label is not available on this site.

09/18/1984 SUPPL-10 Labeling

Label is not available on this site.

03/06/1984 SUPPL-8 Labeling

Label is not available on this site.

06/03/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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