"11509-0426-1" National Drug Code (NDC)

Vagistat 1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
(Combe Incorporated)

NDC Code11509-0426-1
Package Description1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
Product NDC11509-0426
Product Type NameHUMAN OTC DRUG
Proprietary NameVagistat
Non-Proprietary NameTioconazole
Dosage FormOINTMENT
UsageVAGINAL
Start Marketing Date20200729
Marketing Category NameANDA
Application NumberANDA075915
ManufacturerCombe Incorporated
Substance NameTIOCONAZOLE
Strength6.5
Strength Unitg/100g
Pharmacy ClassesAzole Antifungal [EPC], Azoles [CS]

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