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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204179

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NDA 204179 describes RABEPRAZOLE SODIUM, which is a drug marketed by Teva Pharms Usa, Dr Reddys Labs Ltd, Breckenridge Pharm, Aurobindo Pharma Ltd, Lupin Ltd, Torrent Pharms Ltd, Kremers Urban Pharms, Amneal Pharms, and Mylan Pharms Inc, and is included in nine NDAs. It is available from seventeen suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.

The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for NDA: 204179

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

Pharmacology for NDA: 204179

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 204179

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 204179 ANDA Unit Dose Services 50436-0724 50436-0724-1 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-0724-1)
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 204179 ANDA Amneal Pharmaceuticals LLC 65162-724 65162-724-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Jul 31, 2015TE: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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