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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Cantor Fitzgerald
Chinese Patent Office

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065129

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NDA 065129 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 065129
Applicant:Lupin Pharms
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065129
Medical Subject Heading (MeSH) Categories for 065129
Suppliers and Packaging for NDA: 065129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX cefixime FOR SUSPENSION;ORAL 065129 ANDA Lupin Pharmaceuticals, Inc. 68180-202 68180-202-05 6 BOTTLE in 1 CARTON (68180-202-05) > 10 mL in 1 BOTTLE (68180-202-04)
SUPRAX cefixime FOR SUSPENSION;ORAL 065129 ANDA Lupin Pharmaceuticals, Inc. 68180-202 68180-202-02 75 mL in 1 BOTTLE (68180-202-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Feb 23, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Fish and Richardson

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