Drugs@FDA: FDA-Approved Drugs
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. |