Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088956
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/1985 | 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-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/10/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 06/05/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/16/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 06/04/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 07/11/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |