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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078964

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NDA 078964 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: 078964

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

Pharmacology for NDA: 078964

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 078964

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 63187-788-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-788-30)
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 078964 ANDA Proficient Rx LP 63187-788 63187-788-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-788-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Nov 8, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Merck
Queensland Health
Dow
Cantor Fitzgerald
Chubb
Covington
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Federal Trade Commission
Medtronic

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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