Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085873
Company: ALPHARMA US PHARMS
Company: ALPHARMA US PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTABARB | BUTABARBITAL SODIUM | 30MG/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
05/17/1978 | 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 |
---|---|---|---|---|---|
04/29/1991 | SUPPL-54 | Labeling |
Label is not available on this site. |
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05/07/1990 | SUPPL-49 | Labeling |
Label is not available on this site. |
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01/22/1990 | SUPPL-48 | Labeling |
Label is not available on this site. |
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11/22/1988 | SUPPL-43 | Labeling |
Label is not available on this site. |
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11/22/1988 | SUPPL-42 | Labeling |
Label is not available on this site. |
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02/08/1989 | SUPPL-41 | Labeling |
Label is not available on this site. |