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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 202091

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NDA 202091 describes SUPRAX, which is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms, and is included in eight NDAs. It is available from four 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 202091
Applicant:Lupin Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 202091
Medical Subject Heading (MeSH) Categories for 202091
Suppliers and Packaging for NDA: 202091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX cefixime FOR SUSPENSION;ORAL 202091 NDA Lupin Pharmaceuticals, Inc. 27437-207 27437-207-02 10 mL in 1 BOTTLE (27437-207-02)
SUPRAX cefixime FOR SUSPENSION;ORAL 202091 NDA Lupin Pharmaceuticals, Inc. 27437-207 27437-207-03 20 mL in 1 BOTTLE (27437-207-03)
Paragraph IV (Patent) Challenges for 202091
Tradename Dosage Ingredient NDA Submissiondate
SUPRAX FOR SUSPENSION;ORAL cefixime 202091 2016-07-22
SUPRAX FOR SUSPENSION;ORAL cefixime 202091 2014-07-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength500MG/5ML
Approval Date:Feb 20, 2013TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 14, 2028Product Flag?YSubstance Flag?Delist Request?

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