Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011738
Company: ENDO PHARMS
Company: ENDO PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUMORPHAN | OXYMORPHONE HYDROCHLORIDE | 5MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1960 | 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 |
|---|---|---|---|---|---|
| 10/29/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/25/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |