# BUTALBITAL AND ACETAMINOPHEN
> **ANDA214305** · Abbreviated New Drug Application (Generic) · Sponsor: QUAGEN · Approved 2024-02-01
## Drug
- **FDA Application Number:** ANDA214305
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUTALBITAL AND ACETAMINOPHEN
- **Generic name:** BUTALBITAL AND ACETAMINOPHEN
- **Active ingredients:** ACETAMINOPHEN; BUTALBITAL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** QUAGEN
- **Manufacturer:** QUAGEN PHARMACEUTICALS LLC
- **First approval:** 2024-02-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214305)
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