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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213663


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NDA 213663 describes NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in five NDAs. It is available from seventeen suppliers. Additional details are available on the NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; naproxen sodium. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.
Summary for 213663
Tradename:NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Granules
Ingredient:diphenhydramine hydrochloride; naproxen sodium
Patents:0
Pharmacology for NDA: 213663
Mechanism of ActionCyclooxygenase Inhibitors
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 213663
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; naproxen sodium TABLET;ORAL 213663 ANDA TARGET CORPORATION 11673-819 11673-819-08 80 TABLET in 1 BOTTLE (11673-819-08)
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; naproxen sodium TABLET;ORAL 213663 ANDA SAFEWAY 21130-814 21130-814-05 50 TABLET in 1 BOTTLE (21130-814-05)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength25MG;220MG
Approval Date:Sep 24, 2020TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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