# BUTALBITAL AND ACETAMINOPHEN
> **ANDA207313** · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2017-12-27
## Drug
- **FDA Application Number:** ANDA207313
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUTALBITAL AND ACETAMINOPHEN
- **Generic name:** BUTALBITAL AND ACETAMINOPHEN
- **Active ingredients:** ACETAMINOPHEN; BUTALBITAL
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** DR REDDYS LABS SA
- **Manufacturer:** Dr. Reddy's Labratories Inc.
- **First approval:** 2017-12-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207313)
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