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Setid 7ac9cc61 B860 478a 92bf 8a54c89f5b32 Applno 22522 Form Tablet Oral Dosage 250mcg - Drug Product Composition: Roflumilast

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$ API Ref.Price (USD/KG) : 93,611Xls

USFDA APPLICATION NUMBER - 22522 / DOSAGE - TABLET;ORAL - 250MCG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
roflumilast(UNII: 0P6C6ZOP5U)
(roflumilast - UNII:0P6C6ZOP5U)
roflumilast500ug

Inactive Ingredients

Ingredient Name
Torrent Pharmaceuticals Limited
Strides Pharma Science Limited
ALLERGAN, INC.
Cardinal Health
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)   
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)   
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)   
povidone(FZ989GH94E)   
POVIDONE, UNSPECIFIED(FZ989GH94E)   
starch, corn(O8232NY3SJ)