Drugs@FDA: FDA-Approved Drugs
Company: MIKART
| 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 |
|---|---|---|---|---|---|---|---|
| 02/21/1986 | 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 |
|---|---|---|---|---|---|
| 08/13/2002 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/31/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1996 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 08/11/1995 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1992 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1990 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1989 | SUPPL-36 | Bioequivalence |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/04/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/31/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |