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Accenture
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090763

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NDA 090763 describes LANSOPRAZOLE, which is a drug marketed by Labs Liconsa, Natco Pharma Ltd, Sun Pharm Inds Ltd, Krka Tovarna Zdravil, Perrigo R And D, Dexcel Pharma, Wockhardt Ltd, Ani Pharms Inc, Sandoz, Teva Pharms, Kremers Urban Pharms, Ajanta Pharma Ltd, Mylan Pharms Inc, Zydus Hlthcare, Inventia Hlthcare, Dr Reddys Labs Ltd, Wockhardt Usa, Teva Pharms Usa, Rising Pharms Inc, and Sandoz Inc, and is included in twenty-six NDAs. It is available from eighty-three suppliers. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

Summary for NDA: 090763

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090763

Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

Suppliers and Packaging for NDA: 090763

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL 090763 ANDA Mylan Pharmaceuticals Inc. 0378-8015 0378-8015-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-10)
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL 090763 ANDA Mylan Pharmaceuticals Inc. 0378-8015 0378-8015-93 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Nov 10, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Nov 10, 2009TE:ABRLD:No


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Colorcon
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