# BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
> **ANDA213321** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2020-04-08
## Drug
- **FDA Application Number:** ANDA213321
- **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:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GRANULES
- **Manufacturer:** Granules Pharmaceuticals Inc.
- **First approval:** 2020-04-08
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213321)
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