Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080530
Company: HERITAGE PHARMS INC
Company: HERITAGE PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLENE | PROPOXYPHENE HYDROCHLORIDE | 65MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 09/15/1972 | 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 |
|---|---|---|---|---|---|
| 07/31/1989 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1982 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |