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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 204835

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NDA 204835 describes CEFIXIME, which is a drug marketed by Alkem Labs Ltd, Ajenat Pharms, Aurobindo Pharma Ltd, Chartwell Rx, and Fdc Ltd, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the CEFIXIME profile page.

The generic ingredient in CEFIXIME is cefixime. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for 204835

Tradename:	CEFIXIME
Applicant:	Aurobindo Pharma Ltd
Ingredient:	cefixime
Patents:	0

Pharmacology for NDA: 204835

Medical Subject Heading (MeSH) Categories for 204835

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 204835

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFIXIME	cefixime	FOR SUSPENSION;ORAL	204835	ANDA	Aurobindo Pharma Limited	65862-751	65862-751-01	100 mL in 1 BOTTLE (65862-751-01)
CEFIXIME	cefixime	FOR SUSPENSION;ORAL	204835	ANDA	Aurobindo Pharma Limited	65862-751	65862-751-50	50 mL in 1 BOTTLE (65862-751-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Apr 14, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/5ML
Approval Date:	Apr 14, 2015	TE:	AB	RLD:	No

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