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Drug Product Composition: Sulconazole Nitrate

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USFDA APPLICATION NUMBER - 18738 / DOSAGE - SOLUTION;TOPICAL - 1%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULCONAZOLE NITRATE(UNII: 1T89100D5U)
(SULCONAZOLE - UNII:5D9HAA5Q5S)
SULCONAZOLE NITRATE10mg in 1

Inactive Ingredients

Ingredient Name
Sun Pharmaceutical Industries, Inc.
BUTYLATED HYDROXYANISOLE(REK4960K2U)
POLOXAMER 407(TUF2IVW3M2)
POLYSORBATE 20(7T1F30V5YH)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)