Details for New Drug Application (NDA): 019964

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NDA 019964 describes TERAZOL 3, which is a drug marketed by Janssen Pharms and is included in two NDAs. Additional details are available on the TERAZOL 3 profile page.

The generic ingredient in TERAZOL 3 is terconazole. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the terconazole profile page.

Summary for 019964

Tradename:	TERAZOL 3
Applicant:	Janssen Pharms
Ingredient:	terconazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;VAGINAL			Strength	0.8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 21, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 019964

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TERAZOL 3	terconazole	CREAM;VAGINAL	019964-001	Feb 21, 1991	4,358,449	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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