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Drug Product Composition: Azilsartan Medoxomil

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$ API Ref.Price (USD/KG) : 1,436Xls

USFDA APPLICATION NUMBER - 202331 / DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZILSARTAN KAMEDOXOMIL(UNII: WEC6I2K1FC)
(AZILSARTAN - UNII:F9NUX55P23)
AZILSARTAN40mg | 40mg
chlorthalidone(UNII: Q0MQD1073Q)
(chlorthalidone - UNII:Q0MQD1073Q)
chlorthalidone25mg | 12.5mg

Inactive Ingredients

Ingredient Name
Takeda Pharmaceuticals America, Inc.
alcohol(3K9958V90M)
butyl alcohol(8PJ61P6TS3)
cellulose, microcrystalline(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
ferric oxide red(1K09F3G675)
ferrosoferric oxide(XM0M87F357)
fumaric acid(88XHZ13131)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
hypromelloses(3NXW29V3WO)
magnesium stearate(70097M6I30)
mannitol(3OWL53L36A)
polyethylene glycol 8000(Q662QK8M3B)
shellac(46N107B71O)
sodium hydroxide(55X04QC32I)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
water(059QF0KO0R)