Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083089
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPOXYPHENE HYDROCHLORIDE | PROPOXYPHENE HYDROCHLORIDE | 32MG | CAPSULE;ORAL | Discontinued | None | No | No |
PROPOXYPHENE HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
08/13/1973 | 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 |
---|---|---|---|---|---|
06/18/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |