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Setid Ba907153 2639 485b Abd8 Af239eccd4ed Applno 7638 Form Tablet Extended Release Oral Dosage 8mg - Drug Product Composition: Efidac 24 Chlorpheniramine Maleate

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$ API Ref.Price (USD/KG) : 39Xls

USFDA APPLICATION NUMBER - 7638 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Chlorpheniramine Maleate(UNII: V1Q0O9OJ9Z)
(Chlorpheniramine - UNII:3U6IO1965U)
Chlorpheniramine Maleate12mg

Inactive Ingredients

Ingredient Name
Schering Plough HealthCare Products
Acacia(5C5403N26O)
Calcium Sulfate(WAT0DDB505)
Carnauba Wax(R12CBM0EIZ)
Lactose Monohydrate(EWQ57Q8I5X)
Magnesium Stearate(70097M6I30)
Oleic Acid(2UMI9U37CP)
Povidone(FZ989GH94E)
Rosin(88S87KL877)
Starch, Corn(O8232NY3SJ)
Sucrose(C151H8M554)
Talc(7SEV7J4R1U)
Titanium Dioxide(15FIX9V2JP)
Tribasic Calcium Phosphate(91D9GV0Z28)
White Wax(7G1J5DA97F)
Zein(80N308T1NN)