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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 021735

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NDA 021735 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Fougera Pharms Inc, Sun Pharma Canada, and Padagis Israel, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the TERCONAZOLE profile page.

The generic ingredient in TERCONAZOLE is terconazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the terconazole profile page.

Summary for 021735

Tradename:	TERCONAZOLE
Applicant:	Fougera Pharms Inc
Ingredient:	terconazole
Patents:	0

Pharmacology for NDA: 021735

Suppliers and Packaging for NDA: 021735

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERCONAZOLE	terconazole	CREAM;VAGINAL	021735	NDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0347	0168-0347-20	20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)
TERCONAZOLE	terconazole	CREAM;VAGINAL	021735	NDA	A-S Medication Solutions	50090-6299	50090-6299-0	20 g in 1 TUBE, WITH APPLICATOR (50090-6299-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	0.8%
Approval Date:	Oct 1, 2004	TE:	BX	RLD:	Yes

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