Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016768
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTROVIS | QUINESTROL | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| ESTROVIS | QUINESTROL | 0.2MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/26/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-6 | Efficacy |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-5 | Efficacy |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-4 | Efficacy |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |