Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040261
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 500MG;50MG;40MG | 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 |
---|---|---|---|---|---|---|---|
10/28/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40261ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/28/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40261_Butalbital,%20Acetaminophen%20and%20Caffeine.pdf |