Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207476

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NDA 207476 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, Sciegen Pharms Inc, and Zydus Pharms, and is included in thirteen 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 are one hundred and thirty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 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 AvKARE, Inc. 42291-585 42291-585-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-585-30)
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)

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Dow

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