Details for New Drug Application (NDA): 216204

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 Action

Cyclooxygenase 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:	OTC	Dosage:	TABLET;ORAL			Strength	38MG;200MG
Approval Date:	May 31, 2022	TE:		RLD:	No

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