Last Updated: June 26, 2026

Details for New Drug Application (NDA): 217607

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NDA 217607 describes CEFIXIME, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Ajenat Pharms, Chartwell Rx, and Fdc Ltd, and is included in eight 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 217607

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

Pharmacology for NDA: 217607

Medical Subject Heading (MeSH) Categories for 217607

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 217607

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFIXIME	cefixime	CAPSULE;ORAL	217607	ANDA	Aurobindo Pharma Limited	59651-647	59651-647-10	1 BLISTER PACK in 1 CARTON (59651-647-10) / 10 CAPSULE in 1 BLISTER PACK
CEFIXIME	cefixime	CAPSULE;ORAL	217607	ANDA	Aurobindo Pharma Limited	59651-647	59651-647-50	50 CAPSULE in 1 BOTTLE (59651-647-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Mar 23, 2026	TE:	AB	RLD:	No

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