Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040637
Company: WEST-WARD PHARM CORP
Company: WEST-WARD PHARM CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 712.8MG;60MG;32MG | 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 |
---|---|---|---|---|---|---|---|
09/22/2006 | ORIG-1 | Approval |
Label is not available on this site. |