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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210568


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NDA 210568 describes CEFPODOXIME PROXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, and Sandoz, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the CEFPODOXIME PROXETIL profile page.

The generic ingredient in CEFPODOXIME PROXETIL is cefpodoxime proxetil. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefpodoxime proxetil profile page.
Summary for 210568
Tradename:CEFPODOXIME PROXETIL
Applicant:Alkem Labs Ltd
Ingredient:cefpodoxime proxetil
Patents:0
Pharmacology for NDA: 210568
Suppliers and Packaging for NDA: 210568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 210568 ANDA Golden State Medical Supply, Inc. 51407-083 51407-083-20 20 TABLET, FILM COATED in 1 BOTTLE (51407-083-20)
CEFPODOXIME PROXETIL cefpodoxime proxetil TABLET;ORAL 210568 ANDA Golden State Medical Supply, Inc. 51407-084 51407-084-20 20 TABLET, FILM COATED in 1 BOTTLE (51407-084-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:May 18, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:May 18, 2022TE:ABRLD:No

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