Drugs@FDA: FDA-Approved Drugs
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORINYL 1+80 28-DAY | MESTRANOL; NORETHINDRONE | 0.08MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/08/1968 | 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 |
|---|---|---|---|---|---|
| 07/11/1986 | SUPPL-108 | Labeling |
Label is not available on this site. |
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| 10/25/1985 | SUPPL-107 | Labeling |
Label is not available on this site. |
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| 04/16/1985 | SUPPL-106 | Labeling |
Label is not available on this site. |
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| 11/13/1984 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/27/1984 | SUPPL-103 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/30/1984 | SUPPL-102 | Labeling |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-101 | Labeling |
Label is not available on this site. |
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| 05/07/1984 | SUPPL-99 | Labeling |
Label is not available on this site. |
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| 07/26/1983 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-97 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-96 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1983 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/29/1982 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/11/1982 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/20/1980 | SUPPL-79 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/1978 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1977 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 06/14/1977 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 07/01/1977 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 07/01/1977 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 10/14/1980 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 05/16/1975 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 05/16/1975 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/16/1975 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/16/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |