Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016705
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVULEN-28 ETHYNODIOL DIACETATE; MESTRANOL 1MG;0.1MG 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
10/02/1967 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
10/23/1986 SUPPL-42 Labeling

Label is not available on this site.

06/10/1986 SUPPL-41 Labeling

Label is not available on this site.

03/13/1986 SUPPL-40 Labeling

Label is not available on this site.

06/05/1985 SUPPL-39 Labeling

Label is not available on this site.

04/05/1985 SUPPL-38 Labeling

Label is not available on this site.

02/12/1985 SUPPL-37 Labeling

Label is not available on this site.

09/18/1984 SUPPL-36 Labeling

Label is not available on this site.

03/06/1984 SUPPL-34 Labeling

Label is not available on this site.

03/05/1981 SUPPL-20 Labeling

Label is not available on this site.

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