Details for New Drug Application (NDA): 079113

NDA 079113 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 079113

Tradename:	IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Applicant:	Perrigo R And D
Ingredient:	diphenhydramine citrate; ibuprofen
Patents:	0

Pharmacology for NDA: 079113

Mechanism of Action

Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 079113

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	079113	ANDA	L. Perrigo Company	0113-0050	0113-0050-58	1 BOTTLE in 1 CARTON (0113-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	079113	ANDA	L. Perrigo Company	0113-0050	0113-0050-60	1 BOTTLE in 1 CARTON (0113-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	38MG;200MG
Approval Date:	Dec 22, 2008	TE:		RLD:	No

Complete Access Available with Subscription