Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211543
Company: NESHER PHARMS
Company: NESHER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | 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 |
---|---|---|---|---|---|---|---|
07/17/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |