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Setid E18ac1f5 4815 4123 B4c2 Edfc2f73763b Applno 21411 Form Capsule Oral Dosage Eq 18mg Base - Drug Product Composition: Atomoxetine HCl

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USFDA APPLICATION NUMBER - 21411 / DOSAGE - CAPSULE;ORAL - EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0)
(ATOMOXETINE - UNII:ASW034S0B8)
ATOMOXETINE HYDROCHLORIDE18mg

Inactive Ingredients

Ingredient Name
Avera McKennan Hospital
Cardinal Health
Lake Erie Medical DBA Quality Care Products LLC
Prasco Laboratories
REMEDYREPACK INC.
DIMETHICONE(92RU3N3Y1O)
FD&C BLUE NO. 2(L06K8R7DQK)  
FERRIC OXIDE RED(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)  
Gelatin(2G86QN327L) 
Gelatin, Unspecified(2G86QN327L)    
sodium lauryl sulfate(368GB5141J)
STARCH, CORN(O8232NY3SJ)
titanium dioxide(15FIX9V2JP)