Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016861
Company: AAIPHARMA LLC
Company: AAIPHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARVON-N | PROPOXYPHENE NAPSYLATE | 50MG/5ML | SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/09/1971 | 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 |
|---|---|---|---|---|---|
| 04/05/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1992 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/16/1987 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/10/1985 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/20/1981 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/26/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/11/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |