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Details for New Drug Application (NDA): 202176

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NDA 202176 describes LANSOPRAZOLE, which is a drug marketed by Anchen Pharms, Natco Pharma Ltd, Sun Pharma Global, Krka Tovarna Zdravil, Perrigo R And D, Dexcel Pharma, Wockhardt Ltd, Ani Pharms Inc, Sandoz, Teva Pharms, Ajanta Pharma Ltd, Mylan Pharms Inc, Zydus Hlthcare, Dr Reddys Labs Ltd, Wockhardt Usa, Citron Pharma Llc, Teva Pharms Usa, and Sandoz Inc, and is included in twenty-two NDAs. It is available from eighty suppliers. Additional details are available on the LANSOPRAZOLE profile page.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-three 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: 202176

Tradename:
LANSOPRAZOLE
Applicant:
Wockhardt Usa
Ingredient:
lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202176

Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

Suppliers and Packaging for NDA: 202176

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL 202176 ANDA REMEDYREPACK INC. 52125-665 52125-665-02 30 CAPSULE, DELAYED RELEASE in 1 VIAL (52125-665-02)
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL 202176 ANDA Wockhardt Limited 55648-669 55648-669-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55648-669-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:Sep 14, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:Sep 14, 2012TE:ABRLD:No


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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 verifification 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.

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