# BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
> **ANDA215138** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2022-01-26
## Drug
- **FDA Application Number:** ANDA215138
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- **Generic name:** BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- **Active ingredients:** ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** HIKMA
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2022-01-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215138)
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