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Setid Feab3ae1 39a3 4195 8ea3 4a381c0bc454 Applno 21434 Form Tablet Extended Release Oral Dosage 1mg - Drug Product Composition: Pfizer Brand of Alprazolam

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USFDA APPLICATION NUMBER - 21434 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alprazolam(UNII: YU55MQ3IZY)
(alprazolam - UNII:YU55MQ3IZY)
alprazolam2mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Mylan Pharmaceuticals Inc.
Actavis Pharma, Inc.
Amneal Pharmaceuticals LLC
Apotex Corp
Aurobindo Pharma Limited
Impax Generics
Lake Erie Medical DBA Quality Care Products LLC
Preferred Pharmaceuticals Inc.
Rebel Distributors Corp.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Bryant Ranch Prepack
Proficient Rx LP
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)           
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)            
D&C YELLOW NO. 10(35SW5USQ3G)     
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)            
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)            
FD&C YELLOW NO. 6(H77VEI93A8)          
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)          
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T)            
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)        
HYPROMELLOSES(3NXW29V3WO)        
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)        
LACTOSE(J2B2A4N98G)         
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)           
MAGNESIUM STEARATE(70097M6I30)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
SILICON DIOXIDE(ETJ7Z6XBU4)