Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040390
Company: ABLE
Company: ABLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | 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 |
---|---|---|---|---|---|---|---|
07/23/2001 | 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 |
---|---|---|---|---|---|
11/07/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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08/08/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/05/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |