Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016029
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVULEN ETHYNODIOL DIACETATE; MESTRANOL 1MG;0.1MG TABLET;ORAL-20 Discontinued None No No
OVULEN-21 ETHYNODIOL DIACETATE; MESTRANOL 1MG;0.1MG 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
03/23/1966 ORIG-1 Approval Type 1 - New Molecular Entity and 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
10/23/1986 SUPPL-65 Labeling

Label is not available on this site.

06/10/1986 SUPPL-64 Labeling

Label is not available on this site.

03/13/1986 SUPPL-63 Labeling

Label is not available on this site.

06/05/1985 SUPPL-62 Labeling

Label is not available on this site.

04/05/1985 SUPPL-61 Labeling

Label is not available on this site.

02/12/1985 SUPPL-60 Labeling

Label is not available on this site.

09/18/1984 SUPPL-59 Labeling

Label is not available on this site.

03/06/1984 SUPPL-57 Labeling

Label is not available on this site.

06/03/1983 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1983 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1982 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1979 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-35 Labeling

Label is not available on this site.

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