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Details for New Drug Application (NDA): 019641

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NDA 019641 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: 019641

Tradename:
TERAZOL 3
Applicant:
Janssen Pharms
Ingredient:
terconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 019641

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 019641

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOL 3
terconazole
SUPPOSITORY;VAGINAL 019641 NDA Janssen Pharmaceuticals, Inc. 50458-531 50458-531-01 1 DOSE PACK in 1 CARTON (50458-531-01) > 3 SUPPOSITORY in 1 DOSE PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength80MG
Approval Date:May 24, 1988TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
TERAZOL 3
terconazole
SUPPOSITORY;VAGINAL019641-001May 24, 19884,358,449► subscribe
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