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Generated: October 24, 2018

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Details for New Drug Application (NDA): 077149

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NDA 077149 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Nycomed Us, Taro, and Perrigo New York, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the TERCONAZOLE profile page.

The generic ingredient in TERCONAZOLE 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 077149
Tradename:TERCONAZOLE
Applicant:Perrigo New York
Ingredient:terconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077149
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 077149
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERCONAZOLE terconazole SUPPOSITORY;VAGINAL 077149 ANDA Perrigo New York Inc 45802-717 45802-717-08 3 BLISTER PACK in 1 CARTON (45802-717-08) > 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength80MG
Approval Date:Mar 17, 2006TE:ABRLD:No

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