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Setid B1ae980c 375e 4a57 A5f1 4352c921ab77 Applno 18612 Form Gum Chewing Buccal Dosage Eq 2mg Base - Drug Product Composition: Nicotine Bitartrate

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

USFDA APPLICATION NUMBER - 18612 / DOSAGE - GUM, CHEWING;BUCCAL - EQ 2MG BASE

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

Inactive Ingredients

Ingredient Name
American Sales Company
Chain Drug Marketing Association Inc.
CVS Pharmacy
Kroger Company
L. Perrigo Company
Niconovum USA Inc.
A-S Medication Solutions
Amerisource Bergen
BJWC
Cardinal Health
Dolgencorp, LLC
DZA Brands LLC
H E B
Humana Pharmacy, Inc.
Major Pharmaceuticals
Safeway
Sam's West Inc
Shopko Stores Operating Co., LLC
Supervalu Inc
Target Corporation
Topco Associates LLC
Walgreen Company
REMEDYREPACK INC.
ACACIA(5C5403N26O)                 
ACESULFAME POTASSIUM(23OV73Q5G9) 
ALUMINUM OXIDE(LMI26O6933)                     
CALCIUM CARBONATE(H0G9379FGK)  
CARNAUBA WAX(R12CBM0EIZ)
D&C YELLOW NO. 10(35SW5USQ3G)                    
GELATIN(2G86QN327L)        
GELATIN, UNSPECIFIED(2G86QN327L)                    
GLYCERIN(PDC6A3C0OX)                     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                      
HYPROMELLOSES(3NXW29V3WO)                      
MAGNESIUM OXIDE(3A3U0GI71G)                   
MALTITOL(D65DG142WK)                   
MANNITOL(3OWL53L36A)       
MENTHOL(L7T10EIP3A)                 
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)                  
PEPPERMINT OIL(AV092KU4JH)                     
POLACRILIN(RCZ785HI7S)  
POLYSORBATE 60(CAL22UVI4M)                   
POLYSORBATE 80(6OZP39ZG8H)                      
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM CARBONATE(45P3261C7T)
SORBITOL(506T60A25R)  
SUCRALOSE(96K6UQ3ZD4)         
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)      
XYLITOL(VCQ006KQ1E)