Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084553
Company: ALRA
Company: ALRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMPOUND 65 | ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE | 389MG;32.4MG;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 |
|---|---|---|---|---|---|---|---|
| 09/23/1975 | 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 |
|---|---|---|---|---|---|
| 08/17/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |