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Setid 523b3f51 1d52 46ea 85a9 9d01cd29b4f8 Applno 17581 Form Tablet Oral Dosage 250mg - Drug Product Composition: Alpron

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$ API Ref.Price (USD/KG) : 34Xls

USFDA APPLICATION NUMBER - 17581 / DOSAGE - TABLET;ORAL - 250MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
naproxen(UNII: 57Y76R9ATQ)
(naproxen - UNII:57Y76R9ATQ)
naproxen500mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Avera McKennan Hospital
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
NuCare Pharmaceuticals, Inc.
REMEDYREPACK INC.
Unit Dose Services
Major Pharmaceuticals
A-S Medication Solutions LLC
American Health Packaging
Belmora LLC
Bryant Ranch Prepack
Cardinal Health
Cipla USA Inc.
Clinical Solutions Wholesale
Clinical Solutions Wholesale, LLC
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Direct_Rx
Genentech, Inc.
Golden State Medical Supply, Inc.
KAISER FOUNDATION HOSPITALS
Lake Erie Medical DBA Quality Care Products LLC
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
QPharma Inc
REMEDYREPACK INC.
RPK Pharmaceuticals, Inc.
St. Mary's Medical Park Pharmacy
Teva Pharmaceuticals USA, Inc.
Citron Pharma LLC
West-Ward Pharmaceuticals Corp
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                           
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                
CROSCARMELLOSE SODIUM(M28OL1HH48)   
CROSPOVIDONE(68401960MK)                                
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                
FD&C BLUE NO. 2(L06K8R7DQK)                                
FERRIC OXIDE RED(1K09F3G675)             
FERRIC OXIDE YELLOW(EX438O2MRT)            
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                               
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                                
MAGNESIUM STEARATE(70097M6I30) 
methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13)                                
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                        
POLYETHYLENE GLYCOL 400(B697894SGQ)                                
polyethylene glycol 8000(Q662QK8M3B)                                
POVIDONE K12(333AG72FWJ)                                
POVIDONE K29/32(390RMW2PEQ)                                
POVIDONE K30(U725QWY32X)                                
POVIDONE K90(RDH86HJV5Z)                          
POVIDONE(FZ989GH94E)                     
POVIDONE, UNSPECIFIED(FZ989GH94E)                   
POVIDONES(FZ989GH94E)                    
SILICON DIOXIDE(ETJ7Z6XBU4)                   
sodium hydroxide(55X04QC32I)                                
SODIUM LAURYL SULFATE(368GB5141J)                                
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                           
STARCH, CORN(O8232NY3SJ)                          
TALC(7SEV7J4R1U)                               
TITANIUM DIOXIDE(15FIX9V2JP)                                
triethyl citrate(8Z96QXD6UM)                                
water(059QF0KO0R)