You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 7, 2024

Details for New Drug Application (NDA): 207476


✉ Email this page to a colleague

« Back to Dashboard


NDA 207476 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 207476
Pharmacology for NDA: 207476
Suppliers and Packaging for NDA: 207476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476 ANDA ScieGen Pharmaceuticals, Inc. 50228-363 50228-363-05 500 CAPSULE in 1 BOTTLE (50228-363-05)
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476 ANDA ScieGen Pharmaceuticals, Inc. 50228-363 50228-363-30 30 CAPSULE in 1 BOTTLE (50228-363-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;1.1GM
Approval Date:Dec 6, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG;1.1GM
Approval Date:Dec 6, 2016TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.