Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018127
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVCON-35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-21 Discontinued None Yes No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-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1998 SUPPL-33 Labeling

Label is not available on this site.

07/07/1995 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1995 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1995 SUPPL-30 Labeling

Label is not available on this site.

03/12/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-28 Labeling

Label is not available on this site.

04/08/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/25/1995 SUPPL-25 Labeling

Label is not available on this site.

07/21/1992 SUPPL-24 Labeling

Label is not available on this site.

07/24/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/12/1991 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1989 SUPPL-20 Labeling

Label is not available on this site.

03/18/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1984 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/03/1984 SUPPL-14 Labeling

Label is not available on this site.

01/23/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1983 SUPPL-12 Labeling

Label is not available on this site.

02/08/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1982 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.

01/14/1980 SUPPL-5 Labeling

Label is not available on this site.

08/29/1979 SUPPL-4 Manufacturing (CMC)-Packaging

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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English