# BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
> **ANDA207118** · Abbreviated New Drug Application (Generic) · Sponsor: NUVO PHARMS INC · Approved 2016-10-28
## Drug
- **FDA Application Number:** ANDA207118
- **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:** NUVO PHARMS INC
- **Manufacturer:** SUNRISE PHARMACEUTICAL, INC
- **First approval:** 2016-10-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207118)
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