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Setid 78fe4ca0 D9f3 497e B39c 19ddcc4e3ded Applno 18238 Form Capsule Extended Release Oral Dosage 8meq - Drug Product Composition: Chloride, Potassium

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$ API Ref.Price (USD/KG) : 8Xls

USFDA APPLICATION NUMBER - 18238 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(POTASSIUM CATION - UNII:295O53K152)
POTASSIUM CHLORIDE750mg

Inactive Ingredients

Ingredient Name
American Health Packaging
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
REMEDYREPACK INC.
Zydus Pharmaceuticals (USA) Inc.
REMEDYREPACK INC.
ALUMINUM OXIDE(LMI26O6933) 
ETHYLCELLULOSES(7Z8S9VYZ4B) 
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 6(H77VEI93A8) 
GELATIN(2G86QN327L) 
MAGNESIUM STEARATE(70097M6I30) 
SODIUM LAURYL SULFATE(368GB5141J) 
TITANIUM DIOXIDE(15FIX9V2JP)