Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016119
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESLAC | TESTOLACTONE | 100MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1969 | 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 |
|---|---|---|---|---|---|
| 04/27/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1979 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/22/1977 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/06/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |