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Details for New Drug Application (NDA): 050761

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NDA 050761 describes AMOXIL, which is a drug marketed by Dr Reddys Labs Inc and Glaxosmithkline and is included in eight NDAs. It is available from five suppliers. Additional details are available on the AMOXIL profile page.

The generic ingredient in AMOXIL is amoxicillin. There are forty-three drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

Summary for NDA: 050761

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength200MG
Approval Date:Apr 15, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength400MG
Approval Date:Apr 15, 1999TE:RLD:No