Drugs@FDA: FDA-Approved Drugs
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LORCET-HD | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | 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 |
---|---|---|---|---|---|---|---|
07/08/1982 | 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 |
---|---|---|---|---|---|
07/20/2000 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
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06/05/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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12/21/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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12/11/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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11/01/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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09/22/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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09/07/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
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09/19/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/15/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/15/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/08/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/22/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |