Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017553
Company: ALZA
Company: ALZA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROGESTASERT | PROGESTERONE | 38MG | INSERT, EXTENDED RELEASE;INTRAUTERINE | 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 |
|---|---|---|---|---|---|---|---|
| 02/04/1976 | 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 |
|---|---|---|---|---|---|
| 01/28/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1994 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 08/05/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/03/1990 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 03/03/1988 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/19/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/30/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/30/1979 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/08/1977 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/03/1976 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |