Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016659
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORINYL 1+50 28-DAY MESTRANOL; NORETHINDRONE 0.05MG;1MG 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
11/17/1967 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2013 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

12/03/2013 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

01/24/2000 SUPPL-125 Labeling

Label is not available on this site.

05/14/1999 SUPPL-124 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-123 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1997 SUPPL-122 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-121 Labeling

Label is not available on this site.

08/30/1995 SUPPL-120 Labeling

Label is not available on this site.

07/31/1992 SUPPL-119 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-118 Labeling

Label is not available on this site.

10/09/1991 SUPPL-117 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1990 SUPPL-116 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1990 SUPPL-115 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1990 SUPPL-113 Labeling

Label is not available on this site.

07/17/1986 SUPPL-110 Labeling

Label is not available on this site.

10/25/1985 SUPPL-109 Labeling

Label is not available on this site.

04/16/1985 SUPPL-108 Labeling

Label is not available on this site.

11/13/1984 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

07/30/1984 SUPPL-105 Labeling

Label is not available on this site.

06/12/1984 SUPPL-104 Labeling

Label is not available on this site.

09/27/1984 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1984 SUPPL-101 Labeling

Label is not available on this site.

07/26/1983 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-97 Labeling

Label is not available on this site.

07/26/1983 SUPPL-96 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1983 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1982 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1982 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1979 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1977 SUPPL-61 Labeling

Label is not available on this site.

06/14/1977 SUPPL-60 Labeling

Label is not available on this site.

06/14/1977 SUPPL-59 Labeling

Label is not available on this site.

07/01/1977 SUPPL-55 Labeling

Label is not available on this site.

07/01/1977 SUPPL-54 Labeling

Label is not available on this site.

10/14/1980 SUPPL-53 Labeling

Label is not available on this site.

09/29/1976 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-48 Labeling

Label is not available on this site.

05/16/1975 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-37 Labeling

Label is not available on this site.

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