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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216204


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NDA 216204 describes IBUPROFEN AND DIPHENHYDRAMINE CITRATE, which is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc, and is included in four NDAs. It is available from twenty-eight suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE CITRATE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE CITRATE is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 216204
Tradename:IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Applicant:Aurobindo Pharma
Ingredient:diphenhydramine citrate; ibuprofen
Patents:0
Pharmacology for NDA: 216204
Mechanism of ActionCyclooxygenase Inhibitors
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 216204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 216204 ANDA Better Living Brands, LLC 21130-228 21130-228-12 1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE
IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 216204 ANDA Better Living Brands, LLC 21130-228 21130-228-18 1 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength38MG;200MG
Approval Date:May 31, 2022TE:RLD:No

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Preferred Citation:

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