Details for New Drug Application (NDA): 078878

NDA 078878 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D, and is included in eight NDAs. It is available from forty-nine suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 078878

Tradename:	OMEPRAZOLE MAGNESIUM
Applicant:	Dr Reddys Labs Ltd
Ingredient:	omeprazole magnesium
Patents:	0

Pharmacology for NDA: 078878

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 078878

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	078878	ANDA	Walgreens Company	0363-0042	0363-0042-01	3 BOTTLE in 1 CARTON (0363-0042-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	078878	ANDA	Walgreens Company	0363-0042	0363-0042-27	2 BOTTLE in 1 CARTON (0363-0042-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 5, 2009	TE:		RLD:	No

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