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Setid 9793245c C3e0 4351 A2ab B54b46aecb43 Applno 21022 Form Solution Topical Dosage 8 - Drug Product Composition: Loprox cream

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$ API Ref.Price (USD/KG) : 332Xls

USFDA APPLICATION NUMBER - 21022 / DOSAGE - SOLUTION;TOPICAL - 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciclopirox(UNII: 19W019ZDRJ)
(ciclopirox - UNII:19W019ZDRJ)
ciclopirox80mg in 1

Inactive Ingredients

Ingredient Name
Bausch Health Americas, Inc.
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)(389H2R62BD)
ethyl acetate(76845O8NMZ)
isopropyl alcohol(ND2M416302)