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 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. |
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| 01/24/2000 | SUPPL-125 | Labeling |
Label is not available on this site. |
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| 05/14/1999 | SUPPL-124 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1999 | SUPPL-123 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/30/1997 | SUPPL-122 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1994 | SUPPL-121 | Labeling |
Label is not available on this site. |
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| 08/30/1995 | SUPPL-120 | Labeling |
Label is not available on this site. |
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| 07/31/1992 | SUPPL-119 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1994 | SUPPL-118 | Labeling |
Label is not available on this site. |
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| 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. |
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| 11/02/1990 | SUPPL-113 | Labeling |
Label is not available on this site. |
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| 07/17/1986 | SUPPL-110 | Labeling |
Label is not available on this site. |
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| 10/25/1985 | SUPPL-109 | Labeling |
Label is not available on this site. |
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| 04/16/1985 | SUPPL-108 | Labeling |
Label is not available on this site. |
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| 11/13/1984 | SUPPL-106 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 01/11/1982 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 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. |
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| 06/14/1977 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 06/14/1977 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 07/01/1977 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 07/01/1977 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 10/14/1980 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 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. |
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| 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. |