Drugs@FDA: FDA-Approved Drugs
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ANEXSIA | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | 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 |
---|---|---|---|---|---|---|---|
04/23/1987 | 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 |
---|---|---|---|---|---|
11/13/2002 | SUPPL-37 | Labeling |
Label is not available on this site. |
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11/05/2002 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/15/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/19/2002 | SUPPL-34 | Labeling |
Label is not available on this site. |
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09/19/2002 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/11/2002 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/15/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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03/15/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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07/30/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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07/11/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
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05/12/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/21/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/30/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |