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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065380

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NDA 065380 describes SUPRAX, which is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms, and is included in eight NDAs. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SUPRAX profile page.

The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.
Summary for 065380
Tradename:SUPRAX
Applicant:Lupin Ltd
Ingredient:cefixime
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065380
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065380
Suppliers and Packaging for NDA: 065380
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380 ANDA Lupin Pharmaceuticals, Inc. 27437-203 N 27437-203-02
SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380 ANDA Lupin Pharmaceuticals, Inc. 27437-203 N 27437-203-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Oct 25, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength150MG
Approval Date:Oct 25, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength200MG
Approval Date:Oct 25, 2010TE:RLD:No

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