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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075953

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NDA 075953 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 075953

Tradename:	TERCONAZOLE
Applicant:	Sun Pharma Canada
Ingredient:	terconazole
Patents:	0

Pharmacology for NDA: 075953

Suppliers and Packaging for NDA: 075953

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERCONAZOLE	terconazole	CREAM;VAGINAL	075953	ANDA	A-S Medication Solutions	50090-1196	50090-1196-0	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) / 20 g in 1 TUBE, WITH APPLICATOR
TERCONAZOLE	terconazole	CREAM;VAGINAL	075953	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1302	51672-1302-0	1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) / 20 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	0.8%
Approval Date:	Apr 6, 2004	TE:	BX	RLD:	No

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