Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 040701
Company: BOCA PHARMA LLC
Company: BOCA PHARMA LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 04/03/2007 | ORIG-1 | Approval |
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