loader
Please Wait
Applying Filters...

Setid 4cb2ad7a C70d 4647 Bc4d Bac9b5d13b92 Applno 21688 Form Tablet Oral Dosage Eq 30mg Base - Drug Product Composition: Cinacalcet

Menu
$ API Ref.Price (USD/KG) : 2,000Xls

USFDA APPLICATION NUMBER - 21688 / DOSAGE - TABLET;ORAL - EQ 30MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE(UNII: 1K860WSG25)
(CINACALCET - UNII:UAZ6V7728S)
CINACALCET60mg | 30mg

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
A-S Medication Solutions
Avera McKennan Hospital
Cardinal Health
Golden State Medical Supply, Inc.
Accord Healthcare, Inc.
ACI Healthcare USA, Inc
Cipla USA Inc.
EXELAN PHARMACEUTICALS INC.
NorthStar RxLLC
Lupin Pharmaceuticals, Inc.
Mylan Pharmaceuticals Inc.
ALUMINUM OXIDE(LMI26O6933)           
CARNAUBA WAX(R12CBM0EIZ)        
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSPOVIDONE (120 .MU.M)(68401960MK)           
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)          
CROSPOVIDONE(2S7830E561)        
CROSPOVIDONE(68401960MK)          
CROSPOVIDONE, UNSPECIFIED(2S7830E561)          
FD&C BLUE NO. 2(L06K8R7DQK)    
FD&C YELLOW NO. 6(H77VEI93A8)           
FERRIC OXIDE YELLOW(EX438O2MRT)    
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)          
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)         
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)         
HYPROMELLOSES(3NXW29V3WO)         
ISOPROPYL ALCOHOL(ND2M416302)          
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)         
POLOXAMER 407(TUF2IVW3M2)           
POLYETHYLENE GLYCOL 6000(30IQX730WE)           
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)         
POVIDONE K30(U725QWY32X)          
POVIDONE(FZ989GH94E)          
POVIDONE, UNSPECIFIED(FZ989GH94E)          
POVIDONES(FZ989GH94E)          
SILICON DIOXIDE(ETJ7Z6XBU4)   
SODIUM STEARYL FUMARATE(7CV7WJK4UI)           
STARCH, CORN(O8232NY3SJ)   
TITANIUM DIOXIDE(15FIX9V2JP)   
TRIACETIN(XHX3C3X673)