Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040122
Company: WATSON LABS
Company: WATSON LABS
| 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 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 750MG;7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/04/1996 | 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 |
|---|---|---|---|---|---|
| 03/27/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |