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Setid 619add8c 3e39 4bb7 8828 450bd82c0404 Applno 208647 Form Capsule Oral Dosage Eq 10mg Base - Drug Product Composition: X-Plended

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$ API Ref.Price (USD/KG) : 546Xls

USFDA APPLICATION NUMBER - 208647 / DOSAGE - CAPSULE;ORAL - EQ 10MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73)
ROSUVASTATIN40mg | 20mg | 10mg | 5mg

Inactive Ingredients

Ingredient Name
Sun Pharmaceutical Industries, Inc.
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CROSPOVIDONE(2S7830E561)
D&C RED NO. 28(767IP0Y5NH)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
MAGNESIUM OXIDE(3A3U0GI71G)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM LAURYL SULFATE(368GB5141J)
TITANIUM DIOXIDE(15FIX9V2JP)