Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070758
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORETHINDRONE AND MESTRANOL | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/26/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/01/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/04/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/10/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 07/31/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |