Last Updated: September 28, 2026

Details for New Drug Application (NDA): 076850

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NDA 076850 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 six suppliers. Additional details are available on the TERCONAZOLE profile page.

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

Summary for 076850

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;VAGINAL			Strength	80MG
Approval Date:	Jul 12, 2006	TE:		RLD:	No

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