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Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021735

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NDA 021735 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 twelve 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. Fifteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 021735
Tradename:TERCONAZOLE
Applicant:Nycomed Us
Ingredient:terconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021735
Suppliers and Packaging for NDA: 021735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERCONAZOLE terconazole CREAM;VAGINAL 021735 NDA E. FOUGERA & CO. A division of Nycomed US Inc. 0168-0347 0168-0347-20 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)
TERCONAZOLE terconazole CREAM;VAGINAL 021735 NDA Pharmaderm, A division of Nycomed US Inc. 0462-0347 0462-0347-20 20 g in 1 TUBE, WITH APPLICATOR (0462-0347-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.8%
Approval Date:Oct 1, 2004TE:BXRLD:Yes

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