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Setid De96add2 7e96 4633 B205 19b3434010ce Applno 21567 Form Capsule Oral Dosage Eq 200mg Base - Drug Product Composition: ATAZANAVIR SULPHATE

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$ API Ref.Price (USD/KG) : 785Xls

USFDA APPLICATION NUMBER - 21567 / DOSAGE - CAPSULE;ORAL - EQ 200MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE(UNII: 4MT4VIE29P)
(ATAZANAVIR - UNII:QZU4H47A3S)
ATAZANAVIR200mg | 300mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
A-S Medication Solutions LLC
Cipla USA Inc.
Greenstone LLC
REMEDYREPACK INC.
Aurobindo Pharma Limited
NorthStar Rx LLC
American Health Packaging
Golden State Medical Supply Inc.
Major Pharmaceuticals
ALCOHOL(3K9958V90M)     
AMMONIA(5138Q19F1X)     
BUTYL ALCOHOL(8PJ61P6TS3)     
CROSPOVIDONE (120 .MU.M)(68401960MK)       
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)    
CROSPOVIDONE(2S7830E561)         
CROSPOVIDONE(68401960MK)         
D&C YELLOW NO. 10(35SW5USQ3G)       
FD&C BLUE NO. 1(H3R47K3TBD)       
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C RED NO. 3(PN2ZH5LOQY)         
FD&C RED NO. 4(X3W0AM1JLX)         
FD&C RED NO. 40(WZB9127XOA)       
FERRIC OXIDE RED(1K09F3G675)  
FERRIC OXIDE YELLOW(EX438O2MRT)  
FERROSOFERRIC OXIDE(XM0M87F357) 
GELATIN(2G86QN327L)        
GELATIN, UNSPECIFIED(2G86QN327L)  
ISOPROPYL ALCOHOL(ND2M416302)     
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POTASSIUM HYDROXIDE(WZH3C48M4T)    
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM LAURYL SULFATE(368GB5141J)       
SORBITAN MONOLAURATE(6W9PS8B71J)        
TITANIUM DIOXIDE(15FIX9V2JP)