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Generated: November 15, 2018

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Details for New Drug Application (NDA): 065355

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NDA 065355 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. Ten suppliers are listed for this compound. Additional details are available on the cefixime profile page.
Summary for 065355
Tradename:SUPRAX
Applicant:Lupin Pharms
Ingredient:cefixime
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065355
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065355
Suppliers and Packaging for NDA: 065355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX cefixime FOR SUSPENSION;ORAL 065355 ANDA Lupin Pharmaceuticals, Inc. 27437-206 27437-206-01 100 mL in 1 BOTTLE (27437-206-01)
SUPRAX cefixime FOR SUSPENSION;ORAL 065355 ANDA Lupin Pharmaceuticals, Inc. 27437-206 27437-206-02 75 mL in 1 BOTTLE (27437-206-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Apr 10, 2007TE:ABRLD:No

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