loader
Please Wait
Applying Filters...

Setid 87e29ef9 Bdfe 4a84 8ee0 A325c15a3487 Applno 205122 Form Capsule Extended Release Oral Dosage 200mg - Drug Product Composition: Topiramato

Menu
$ API Ref.Price (USD/KG) : 179Xls

USFDA APPLICATION NUMBER - 205122 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391)
TOPIRAMATE100mg

Inactive Ingredients

Ingredient Name
Glenmark Pharmaceuticals Inc., USA
NorthStar RxLLC
REMEDYREPACK INC.
AMMONIA(5138Q19F1X) 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
D&C RED NO. 30(2S42T2808B) 
DIETHYL PHTHALATE(UF064M00AF)  
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 5(I753WB2F1M) 
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) 
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
POLYETHYLENE GLYCOL 6000(30IQX730WE) 
POTASSIUM HYDROXIDE(WZH3C48M4T) 
PROPYLENE GLYCOL(6DC9Q167V3) 
SHELLAC(46N107B71O) 
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)