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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 075915


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NDA 075915 describes TIOCONAZOLE, which is a drug marketed by Perrigo and is included in one NDA. It is available from eighteen suppliers. Additional details are available on the TIOCONAZOLE profile page.

The generic ingredient in TIOCONAZOLE is tioconazole. There are three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the tioconazole profile page.
Summary for 075915
Tradename:TIOCONAZOLE
Applicant:Perrigo
Ingredient:tioconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075915
Suppliers and Packaging for NDA: 075915
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIOCONAZOLE tioconazole OINTMENT;VAGINAL 075915 ANDA L. Perrigo Company 0113-0426 0113-0426-54 1 POUCH in 1 CARTON (0113-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
TIOCONAZOLE tioconazole OINTMENT;VAGINAL 075915 ANDA Walgreen Company 0363-0426 0363-0426-54 1 POUCH in 1 CARTON (0363-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:OINTMENT;VAGINALStrength6.5%
Approval Date:Nov 21, 2001TE:RLD:No

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