Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076528
Company: ABLE
Company: ABLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Discontinued | None | No | No |
| BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE | BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE | 40MG/30MG | Capsule; Oral | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 08/21/2003 | ORIG-1 | Approval |
Label is not available on this site. |