Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019762
Company: ALZA
Company: ALZA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTODERM | TESTOSTERONE | 4MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| TESTODERM | TESTOSTERONE | 6MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/12/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 12/17/1997 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/28/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/26/1996 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |