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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Argus Health
Daiichi Sankyo
Boehringer Ingelheim

Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050575

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NDA 050575 describes AUGMENTIN '250', which is a drug marketed by Dr Reddys Labs Inc and is included in three NDAs. It is available from five suppliers. Additional details are available on the AUGMENTIN '250' profile page.

The generic ingredient in AUGMENTIN '250' is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 050575

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050575

Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050575

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050575 NDA Rebel Distributors Corp 42254-282 42254-282-00 100 mL in 1 BOTTLE (42254-282-00)
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050575 NDA Dr. Reddy's Laboratories Inc 43598-004 43598-004-51 75 mL in 1 BOTTLE (43598-004-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date:Aug 6, 1984TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date:Aug 6, 1984TE:ABRLD:Yes

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Serving 500+ biopharmaceutical companies globally:

US Army
US Department of Justice
Farmers Insurance
Daiichi Sankyo
Federal Trade Commission
Harvard Business School
Boehringer Ingelheim

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