Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070751
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALBUPHINE | NALBUPHINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | No | No |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/1986 | 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 |
|---|---|---|---|---|---|
| 02/20/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/09/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/12/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |