Details for New Drug Application (NDA): 203345

NDA 203345 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-five suppliers. Additional details are available on the OMEPRAZOLE AND SODIUM BICARBONATE profile page.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for 203345

Tradename:	OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:	Zydus
Ingredient:	omeprazole; sodium bicarbonate
Patents:	0

Pharmacology for NDA: 203345

Mechanism of Action

Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 203345

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203345	ANDA	Zydus Pharmaceuticals USA Inc.	68382-503	68382-503-04	3 BOTTLE in 1 CARTON (68382-503-04) / 14 CAPSULE in 1 BOTTLE
OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203345	ANDA	Zydus Pharmaceuticals USA Inc.	68382-503	68382-503-17	2 BOTTLE in 1 CARTON (68382-503-17) / 14 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	20MG;1.1GM
Approval Date:	Mar 16, 2018	TE:		RLD:	No

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