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Generated: October 23, 2018

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Details for New Drug Application (NDA): 019579

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NDA 019579 describes TERAZOL 7, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the TERAZOL 7 profile page.

The generic ingredient in TERAZOL 7 is terconazole. There are six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 019579
Tradename:TERAZOL 7
Applicant:Janssen Pharms
Ingredient:terconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019579
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 019579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERAZOL 7 terconazole CREAM;VAGINAL 019579 NDA AUTHORIZED GENERIC Actavis Pharma, Inc 0591-3196 0591-3196-89 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3196-89) > 45 g in 1 TUBE, WITH APPLICATOR
TERAZOL 7 terconazole CREAM;VAGINAL 019579 NDA H.J. Harkins Company, Inc. 52959-811 52959-811-03 45 g in 1 TUBE, WITH APPLICATOR (52959-811-03)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrength0.4%
Approval Date:Dec 31, 1987TE:RLD:Yes

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