Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010753
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADURIN | POLYESTRADIOL PHOSPHATE | 40MG/AMP | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1957 | 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 |
|---|---|---|---|---|---|
| 09/06/1990 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/14/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/01/1981 | SUPPL-12 | Efficacy |
Label is not available on this site. |
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| 06/15/1981 | SUPPL-11 | Efficacy |
Label is not available on this site. |
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| 12/13/1979 | SUPPL-10 | Efficacy |
Label is not available on this site. |
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| 12/13/1979 | SUPPL-9 | Efficacy |
Label is not available on this site. |
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| 12/13/1979 | SUPPL-8 | Efficacy |
Label is not available on this site. |