Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070254
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/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 |
|---|---|---|---|---|---|---|---|
| 01/07/1987 | 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 |
|---|---|---|---|---|---|
| 12/13/2006 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/31/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 07/11/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |