# BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
> **ANDA076528** · Abbreviated New Drug Application (Generic) · Sponsor: ABLE · Approved 2003-08-21
## Drug
- **FDA Application Number:** ANDA076528
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
- **Generic name:** Butalbital
- **Active ingredients:** BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
- **Dosage form:** Capsule
- **Route:** Oral
- **Marketing status:** Prescription
- **Sponsor:** ABLE
- **First approval:** 2003-08-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076528)
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