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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. It is available from six suppliers. 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. Sixteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.

Summary for NDA: 019964

Janssen Pharms
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 019964


Suppliers and Packaging for NDA: 019964

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;VAGINAL 019964 NDA AUTHORIZED GENERIC Actavis Pharma, Inc 0591-3197 0591-3197-52 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3197-52) > 20 g in 1 TUBE, WITH APPLICATOR
CREAM;VAGINAL 019964 NDA Rebel Distributors Corp 21695-933 21695-933-20 20 g in 1 TUBE, WITH APPLICATOR (21695-933-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.8%
Approval Date:Feb 21, 1991TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019964

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
CREAM;VAGINAL019964-001Feb 21, 19914,358,449<disabled>
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