# BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
> **ANDA040864** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2008-12-01
## Drug
- **FDA Application Number:** ANDA040864
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- **Generic name:** BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- **Active ingredients:** ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GRANULES
- **Manufacturer:** Granules Pharmaceuticals Inc.
- **First approval:** 2008-12-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040864)
---
*AI Analytics · CC0 1.0*