Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081223
Company: MIKART
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 650MG;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/29/1992 | 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-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/31/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/31/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/31/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/31/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/31/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |