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Generated: September 20, 2018

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Details for New Drug Application (NDA): 077553

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NDA 077553 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 077553
Tradename:TERCONAZOLE
Applicant:Taro
Ingredient:terconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077553
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 077553
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERCONAZOLE terconazole SUPPOSITORY;VAGINAL 077553 ANDA G & W Laboratories, Inc. 0713-0552 0713-0552-73 3 BLISTER PACK in 1 CARTON (0713-0552-73) > 1 SUPPOSITORY in 1 BLISTER PACK
TERCONAZOLE terconazole SUPPOSITORY;VAGINAL 077553 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1330 51672-1330-3 1 DOSE PACK in 1 CARTON (51672-1330-3) > 3 SUPPOSITORY in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;VAGINALStrength80MG
Approval Date:Mar 9, 2007TE:ABRLD:No

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