# ACETAMINOPHEN AND IBUPROFEN
> **ANDA219053** · Abbreviated New Drug Application (Generic) · Sponsor: TARO · Approved 2026-01-02
## Drug
- **FDA Application Number:** ANDA219053
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ACETAMINOPHEN AND IBUPROFEN
- **Generic name:** ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS
- **Active ingredients:** ACETAMINOPHEN; IBUPROFEN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** TARO
- **Manufacturer:** Sun Pharmaceutical Industries, Inc.
- **First approval:** 2026-01-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219053)
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