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Generated: July 24, 2017

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 Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, Perrigo R And D, Dr Reddys Labs Ltd, and Sciegen Pharms Inc, and is included in eleven NDAs. It is available from fourteen 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-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

Summary for NDA: 079182

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 49884-268-11 30 PACKET in 1 CARTON (49884-268-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-268-52)
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL 079182 ANDA Par Pharmaceutical, Inc. 49884-269 49884-269-11 30 PACKET in 1 CARTON (49884-269-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-269-52)

Summary for product number 001

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Teva
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Federal Trade Commission
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