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Setid E2751358 86f7 4e09 82d2 8fdea41ae202 Applno 21330 Form Troche Lozenge Oral Dosage Eq 4mg Base - Drug Product Composition: Nicotine

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$ API Ref.Price (USD/KG) : 108Xls

USFDA APPLICATION NUMBER - 21330 / DOSAGE - TROCHE/LOZENGE;ORAL - EQ 4MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE(UNII: 6M3C89ZY6R)
(NICOTINE - UNII:6M3C89ZY6R)
NICOTINE4mg | 2mg | 4mg | 2mg

Inactive Ingredients

Ingredient Name
Kroger Company
Walgreens
Big Lots Stores, Inc.
Cardinal Health
CVS Pharmacy
H E B
L. Perrigo Company
Niconovum USA Inc.
Shopko Stores Operating Co., LLC
A-S Medication Solutions
American Sales Company
DZA Brands LLC
Sam's West Inc
Supervalu Inc
ACACIA(5C5403N26O)            
ACESULFAME POTASSIUM(23OV73Q5G9)     
ASPARTAME(Z0H242BBR1)   
BENZYL ALCOHOL(LKG8494WBH)            
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)            
CALCIUM POLYCARBOPHIL(8F049NKY49)      
COCONUT OIL(Q9L0O73W7L)            
CORN SYRUP(9G5L16BK6N)            
EUGENOL(3T8H1794QW)            
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)            
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)            
MANNITOL(3OWL53L36A)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)            
PALM KERNEL OIL(B0S90M0233)            
POLACRILIN(RCZ785HI7S)
POTASSIUM BICARBONATE(HM5Z15LEBN)
SODIUM ALGINATE(C269C4G2ZQ)
SODIUM CARBONATE(45P3261C7T)
SOY PROTEIN(R44IWB3RN5)            
SUCRALOSE(96K6UQ3ZD4)      
TRIETHYL CITRATE(8Z96QXD6UM)            
XANTHAN GUM(TTV12P4NEE)