Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089696
Company: IVAX PHARMS
Company: IVAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/1988 | 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 |
|---|---|---|---|---|---|
| 01/31/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |