Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013625
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORINYL MESTRANOL; NORETHINDRONE 0.1MG;2MG TABLET;ORAL-20 Discontinued None No No
NORINYL 1+50 21-DAY MESTRANOL; 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
03/05/1964 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/24/2000 SUPPL-181 Labeling

Label is not available on this site.

05/14/1999 SUPPL-180 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-179 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1997 SUPPL-178 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-177 Labeling

Label is not available on this site.

08/30/1995 SUPPL-176 Labeling

Label is not available on this site.

07/31/1992 SUPPL-175 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-174 Labeling

Label is not available on this site.

10/09/1991 SUPPL-173 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1990 SUPPL-172 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1990 SUPPL-171 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1990 SUPPL-169 Labeling

Label is not available on this site.

10/22/1986 SUPPL-166 Labeling

Label is not available on this site.

07/17/1986 SUPPL-165 Labeling

Label is not available on this site.

10/25/1985 SUPPL-164 Labeling

Label is not available on this site.

10/25/1985 SUPPL-163 Labeling

Label is not available on this site.

06/19/1985 SUPPL-162 Labeling

Label is not available on this site.

04/16/1985 SUPPL-161 Labeling

Label is not available on this site.

11/13/1984 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

07/30/1984 SUPPL-158 Labeling

Label is not available on this site.

06/12/1984 SUPPL-157 Labeling

Label is not available on this site.

09/27/1984 SUPPL-155 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1984 SUPPL-154 Labeling

Label is not available on this site.

07/29/1982 SUPPL-145 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1979 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-130 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1979 SUPPL-129 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1979 SUPPL-128 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-127 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-126 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-125 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1977 SUPPL-104 Labeling

Label is not available on this site.

11/22/1977 SUPPL-103 Labeling

Label is not available on this site.

06/14/1977 SUPPL-100 Labeling

Label is not available on this site.

06/14/1977 SUPPL-99 Labeling

Label is not available on this site.

06/14/1977 SUPPL-98 Labeling

Label is not available on this site.

05/26/1977 SUPPL-97 Labeling

Label is not available on this site.

05/26/1977 SUPPL-96 Labeling

Label is not available on this site.

06/14/1977 SUPPL-95 Labeling

Label is not available on this site.

06/14/1977 SUPPL-92 Labeling

Label is not available on this site.

05/26/1977 SUPPL-87 Labeling

Label is not available on this site.

05/26/1977 SUPPL-86 Labeling

Label is not available on this site.

07/01/1977 SUPPL-85 Labeling

Label is not available on this site.

05/16/1975 SUPPL-82 Labeling

Label is not available on this site.

05/16/1975 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1975 SUPPL-72 Labeling

Label is not available on this site.

07/26/1983 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1983 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-50 Labeling

Label is not available on this site.

07/26/1983 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1983 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1982 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1982 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

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