Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087550
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
10/19/1984 | 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 |
---|---|---|---|---|---|
11/12/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/26/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/08/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |