Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084287
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLTESTOSTERONE | METHYLTESTOSTERONE | 10MG | TABLET;BUCCAL, SUBLINGUAL | 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 |
---|---|---|---|---|---|---|---|
07/16/1974 | 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 |
---|---|---|---|---|---|
10/29/1997 | SUPPL-66 | Labeling |
Label is not available on this site. |
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10/09/1991 | SUPPL-65 | Labeling |
Label is not available on this site. |
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07/05/1991 | SUPPL-64 | Labeling |
Label is not available on this site. |
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01/19/1990 | SUPPL-63 | Labeling |
Label is not available on this site. |
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11/28/1989 | SUPPL-62 | Labeling |
Label is not available on this site. |
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07/20/1989 | SUPPL-61 | Labeling |
Label is not available on this site. |
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05/11/1989 | SUPPL-60 | Labeling |
Label is not available on this site. |
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10/31/1988 | SUPPL-59 | Labeling |
Label is not available on this site. |
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07/06/1988 | SUPPL-58 | Labeling |
Label is not available on this site. |