Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017716
Company: WARNER CHILCOTT LLC
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ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None Yes No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
03/29/1976 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
12/21/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/14/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1998 SUPPL-45 Labeling

Label is not available on this site.

07/07/1995 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1995 SUPPL-43 Labeling

Label is not available on this site.

03/12/1993 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/12/1993 SUPPL-39 Labeling

Label is not available on this site.

02/14/1995 SUPPL-38 Labeling

Label is not available on this site.

07/21/1992 SUPPL-37 Labeling

Label is not available on this site.

07/24/1991 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/12/1991 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1989 SUPPL-33 Labeling

Label is not available on this site.

03/18/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1984 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/03/1984 SUPPL-28 Labeling

Label is not available on this site.

01/23/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1983 SUPPL-26 Labeling

Label is not available on this site.

02/08/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1982 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1981 SUPPL-22 Labeling

Label is not available on this site.

01/14/1980 SUPPL-19 Labeling

Label is not available on this site.

08/28/1979 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1979 SUPPL-17 Labeling

Label is not available on this site.

01/19/1979 SUPPL-15 Labeling

Label is not available on this site.

10/20/1978 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/08/1978 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/14/1978 SUPPL-12 Labeling

Label is not available on this site.

10/18/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1978 SUPPL-9 Labeling

Label is not available on this site.

07/14/1978 SUPPL-8 Labeling

Label is not available on this site.

04/28/1978 SUPPL-6 Labeling

Label is not available on this site.

04/30/1976 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