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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079182

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NDA 079182 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc, and is included in eleven NDAs. It is available from eighteen 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 twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 079182
Tradename:OMEPRAZOLE AND SODIUM BICARBONATE
Applicant:Par Pharm
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079182
Suppliers and Packaging for NDA: 079182
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182 ANDA Par Pharmaceutical, Inc. 49884-268 N 49884-268-11
OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182 ANDA Par Pharmaceutical, Inc. 49884-269 N 49884-269-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Apr 19, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/PACKET;1.68GM/PACKET
Approval Date:Apr 19, 2013TE:ABRLD:No

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