Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088758
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/1985 | 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 |
|---|---|---|---|---|---|
| 04/13/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 03/20/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 06/03/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |