Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018128
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVCON-50 ETHINYL ESTRADIOL; NORETHINDRONE 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
07/05/1978 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
11/14/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1995 SUPPL-27 Labeling

Label is not available on this site.

03/12/1993 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-25 Labeling

Label is not available on this site.

05/24/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/21/1992 SUPPL-23 Labeling

Label is not available on this site.

01/02/1991 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1989 SUPPL-19 Labeling

Label is not available on this site.

03/18/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1984 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/03/1984 SUPPL-12 Labeling

Label is not available on this site.

03/25/1983 SUPPL-11 Labeling

Label is not available on this site.

02/08/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1981 SUPPL-8 Labeling

Label is not available on this site.

01/22/1980 SUPPL-5 Labeling

Label is not available on this site.

07/31/1979 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/04/1979 SUPPL-3 Labeling

Label is not available on this site.

01/19/1979 SUPPL-1 Labeling

Label is not available on this site.

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