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Setid 5c6c7ba4 6d42 4e07 A127 B3cf72c866ad Applno 21937 Form Tablet Oral Dosage 600mg 200mg 300mg - Drug Product Composition: Efavirenz

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$ API Ref.Price (USD/KG) : 105Xls

USFDA APPLICATION NUMBER - 21937 / DOSAGE - TABLET;ORAL - 600MG;200MG;300MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
efavirenz(UNII: JE6H2O27P8)
(efavirenz - UNII:JE6H2O27P8)
efavirenz600mg
emtricitabine(UNII: G70B4ETF4S)
(emtricitabine - UNII:G70B4ETF4S)
emtricitabine200mg
tenofovir disoproxil fumarate(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
tenofovir disoproxil fumarate300mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Avera McKennan Hospital
Cipla USA Inc.
Exelan Pharmaceuticals, Inc.
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
American Health Packaging
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT)     
FERROSOFERRIC OXIDE(XM0M87F357)   
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)     
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)      
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)    
HYDROXYPROPYL CELLULOSE(RFW2ET671P)      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
ISOPROPYL ALCOHOL(ND2M416302)     
LECITHIN, SOYBEAN(1DI56QDM62)     
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)  
POLYVINYL ALCOHOL(532B59J990)   
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)  
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)