Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040688
Company: WRASER PHARMS LLC
Company: WRASER PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 356.4MG;30MG;16MG | CAPSULE;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 |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/24/2008 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2008 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |