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Setid 89394e35 F134 4e47 91a5 0cbf14dbe793 Applno 18163 Form Capsule Oral Dosage 30mg - Drug Product Composition: Temazepam

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$ API Ref.Price (USD/KG) : 375Xls

USFDA APPLICATION NUMBER - 18163 / DOSAGE - CAPSULE;ORAL - 30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMAZEPAM(UNII: CHB1QD2QSS)
(TEMAZEPAM - UNII:CHB1QD2QSS)
TEMAZEPAM7.5mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
American Health Packaging
Bryant Ranch Prepack
Liberty Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc
REMEDYREPACK INC.
Sandoz Inc
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
Cardinal Health
KAISER FOUNDATION HOSPITALS
Qualitest Pharmaceuticals
Aphena Pharma Solutions - Tennessee, LLC
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
A-S Medication Solutions
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Proficient Rx LP
ALCOHOL(3K9958V90M)              
ammonia(5138Q19F1X)             
anhydrous lactose(3SY5LH9PMK)               
BENZYL ALCOHOL(LKG8494WBH)                 
BUTYL ALCOHOL(8PJ61P6TS3)           
BUTYLPARABEN(3QPI1U3FV8)                 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)               
CROSCARMELLOSE SODIUM(M28OL1HH48)                   
D&C RED NO. 28(767IP0Y5NH)                  
D&C YELLOW NO. 10(35SW5USQ3G)      
EDETATE CALCIUM DISODIUM(25IH6R4SGF)                 
EDETATE DISODIUM(7FLD91C86K)                   
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK)         
FD&C GREEN NO. 3(3P3ONR6O1S)                 
FD&C RED NO. 3(PN2ZH5LOQY)                  
FD&C RED NO. 40(WZB9127XOA)       
FD&C YELLOW NO. 6(H77VEI93A8)      
FERRIC OXIDE RED(1K09F3G675)                  
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN(2G86QN327L)         
GELATIN, UNSPECIFIED(2G86QN327L)         
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                 
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                 
ISOPROPYL ALCOHOL(ND2M416302)              
LACTOSE MONOHYDRATE(EWQ57Q8I5X)               
LACTOSE(J2B2A4N98G)                  
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)                 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                   
potassium hydroxide(WZH3C48M4T)             
POWDERED CELLULOSE(SMD1X3XO9M)           
PROPYLENE GLYCOL(6DC9Q167V3)  
PROPYLPARABEN(Z8IX2SC1OH)                 
SHELLAC(46N107B71O) 
SILICON DIOXIDE(ETJ7Z6XBU4)        
SODIUM LAURYL SULFATE(368GB5141J) 
SODIUM PROPIONATE HYDRATE(DK6Y9P42IN)                   
SODIUM PROPIONATE(DK6Y9P42IN)                  
STARCH, CORN(O8232NY3SJ)         
TITANIUM DIOXIDE(15FIX9V2JP)