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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017576
Company: WARNER CHILCOTT LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVCON-50 ETHINYL ESTRADIOL; NORETHINDRONE 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-28 Discontinued None No No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
08/28/1975 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
07/22/2008 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017576s051ltr.pdf
12/21/1998 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.
11/14/1997 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.
06/05/1997 SUPPL-46 Labeling

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.
02/14/1995 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/25/1995 SUPPL-42 Labeling

Label is not available on this site.
03/12/1993 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
03/12/1993 SUPPL-40 Labeling

Label is not available on this site.
05/24/1994 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
07/21/1992 SUPPL-37 Labeling

Label is not available on this site.
01/02/1991 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.
01/10/1986 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
09/27/1984 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/03/1984 SUPPL-26 Labeling

Label is not available on this site.
03/25/1983 SUPPL-25 Labeling

Label is not available on this site.
02/08/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
04/14/1981 SUPPL-21 Labeling

Label is not available on this site.
01/22/1980 SUPPL-18 Labeling

Label is not available on this site.
07/31/1979 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/04/1979 SUPPL-16 Labeling

Label is not available on this site.
01/23/1979 SUPPL-14 Labeling

Label is not available on this site.
10/20/1978 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/08/1978 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
07/14/1978 SUPPL-11 Labeling

Label is not available on this site.
10/18/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
03/12/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
04/28/1978 SUPPL-8 Labeling

Label is not available on this site.
07/14/1978 SUPPL-7 Labeling

Label is not available on this site.
04/28/1978 SUPPL-6 Labeling

Label is not available on this site.
05/03/1976 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/22/2008 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf
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