Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074359
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE | ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1995 | 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 |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-14 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 07/31/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/05/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |