# NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
> **ANDA213663** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2020-09-24
## Drug
- **FDA Application Number:** ANDA213663
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- **Generic name:** NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL
- **Active ingredients:** DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** GRANULES
- **Manufacturer:** Granules India Ltd
- **First approval:** 2020-09-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213663)
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