Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074654
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 385MG;30MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 770MG;60MG;50MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/1996 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |