Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204137

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NDA 204137 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, Strides Pharma Intl, Zydus, Zydus Pharms, and Novitium Pharma, and is included in sixteen NDAs. It is available from twenty 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 is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for 204137

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG;1.1GM
Approval Date:	Jul 15, 2016	TE:		RLD:	No

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