Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081226
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 | 500MG/15ML;5MG/15ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 10/27/1992 | 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-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/18/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |