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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 210574

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NDA 210574 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 four 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. Five suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for 210574

Tradename:	CEFIXIME
Applicant:	Alkem Labs Ltd
Ingredient:	cefixime
Patents:	0

Pharmacology for NDA: 210574

Medical Subject Heading (MeSH) Categories for 210574

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 210574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFIXIME	cefixime	CAPSULE;ORAL	210574	ANDA	Ascend Laboratories, LLC	67877-584	67877-584-01	100 CAPSULE in 1 BOTTLE (67877-584-01)
CEFIXIME	cefixime	CAPSULE;ORAL	210574	ANDA	Ascend Laboratories, LLC	67877-584	67877-584-05	500 CAPSULE in 1 BOTTLE (67877-584-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Oct 9, 2018	TE:	AB	RLD:	No

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