Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020200
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 1.5MG/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 |
|---|---|---|---|---|---|---|---|
| 03/12/1993 | 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 |
|---|---|---|---|---|---|
| 10/31/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |