Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070189
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NALOXONE | NALOXONE HYDROCHLORIDE | 0.02MG/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 |
|---|---|---|---|---|---|---|---|
| 10/02/1985 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/070189.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |