Details for New Drug Application (NDA): 090397

NDA 090397 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, and Onesource Specialty, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.

Summary for 090397

Tradename:	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Bionpharma
Ingredient:	diphenhydramine hydrochloride; ibuprofen
Patents:	0

Pharmacology for NDA: 090397

Mechanism of Action

Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 090397

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	090397	ANDA	WALGREEN COMPANY	0363-0207	0363-0207-11	1 BOTTLE in 1 CARTON (0363-0207-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	090397	ANDA	WALGREEN COMPANY	0363-0207	0363-0207-15	1 BOTTLE in 1 CARTON (0363-0207-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:	Nov 22, 2010	TE:		RLD:	No

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