Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087743
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROXIPRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;4.5MG;0.38MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/04/1982 | 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 |
---|---|---|---|---|---|
02/11/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/11/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/12/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |