# NAPROXEN SODIUM
> **ANDA214463** · Abbreviated New Drug Application (Generic) · Sponsor: PATHEON SOFTGELS · Approved 2023-01-10
## Drug
- **FDA Application Number:** ANDA214463
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NAPROXEN SODIUM
- **Generic name:** NAPROXEN SODIUM
- **Active ingredients:** NAPROXEN SODIUM
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** PATHEON SOFTGELS
- **Manufacturer:** Bayer Healthcare LLC
- **First approval:** 2023-01-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214463)
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