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Generated: October 23, 2018

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Details for New Drug Application (NDA): 076043

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NDA 076043 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 076043
Formulation / Manufacturing:see details
Pharmacology for NDA: 076043
Suppliers and Packaging for NDA: 076043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERCONAZOLE terconazole CREAM;VAGINAL 076043 ANDA Rebel Distributors Corp 21695-844 21695-844-45 1 TUBE in 1 CARTON (21695-844-45) > 45 g in 1 TUBE
TERCONAZOLE terconazole CREAM;VAGINAL 076043 ANDA A-S Medication Solutions 50090-0917 50090-0917-0 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-0917-0) > 45 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrength0.4%
Approval Date:Jan 19, 2005TE:ABRLD:No

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