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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Dow
Medtronic
Harvard Business School
Daiichi Sankyo
Moodys
Express Scripts
Teva
Covington

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050754

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NDA 050754 describes AMOXIL, which is a drug marketed by Dr Reddys Labs Inc and Glaxosmithkline and is included in eight NDAs. It is available from three suppliers. Additional details are available on the AMOXIL profile page.

The generic ingredient in AMOXIL is amoxicillin. There are forty-five drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
Summary for 050754
Tradename:AMOXIL
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050754
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 050754
Suppliers and Packaging for NDA: 050754
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXIL amoxicillin TABLET;ORAL 050754 NDA Dr Reddys Laboratories Inc 43598-219 N 43598-219-14
AMOXIL amoxicillin TABLET;ORAL 050754 NDA Dr Reddys Laboratories Inc 43598-219 N 43598-219-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 10, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 10, 1998TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
McKinsey
Farmers Insurance
Fuji
Citi
Medtronic
Accenture
Covington

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