Details for New Drug Application (NDA): 203200

NDA 203200 describes IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Perrigo R And D and is included in one NDA. It is available from five suppliers. Additional details are available on the IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.

Summary for 203200

Tradename:	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Applicant:	Perrigo R And D
Ingredient:	ibuprofen; phenylephrine hydrochloride
Patents:	0

Pharmacology for NDA: 203200

Mechanism of Action

Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 203200

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	Rite Aid Corporation	11822-5158	11822-5158-0	20 BLISTER PACK in 1 CARTON (11822-5158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	203200	ANDA	H E B	37808-158	37808-158-60	20 BLISTER PACK in 1 CARTON (37808-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	200MG;10MG
Approval Date:	Jul 3, 2014	TE:		RLD:	No

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