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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 209726


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NDA 209726 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 sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.
Summary for 209726
Tradename:NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Amneal Pharms Co
Ingredient:diphenhydramine hydrochloride; naproxen sodium
Patents:0
Pharmacology for NDA: 209726
Mechanism of ActionCyclooxygenase Inhibitors
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 209726
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 209726 ANDA Strategic Sourcing Services LLC 62011-0396 62011-0396-1 1 BOTTLE, PLASTIC in 1 BOX (62011-0396-1) / 20 TABLET in 1 BOTTLE, PLASTIC
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; naproxen sodium TABLET;ORAL 209726 ANDA Amneal Pharmaceuticals NY LLC 69238-1422 69238-1422-2 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength25MG;220MG
Approval Date:Oct 23, 2018TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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