Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010611
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOTESTIN | FLUOXYMESTERONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOTESTIN | FLUOXYMESTERONE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOTESTIN | FLUOXYMESTERONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/1956 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 05/20/1991 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 05/20/1991 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 11/02/1990 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 05/05/1989 | SUPPL-35 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/05/1989 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/05/1987 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 06/18/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 06/14/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |