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USFDA APPLICATION NUMBER - 22426 / DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Alogliptin Benzoate(UNII: EEN99869SC) (Alogliptin - UNII:JHC049LO86) | Alogliptin | 12.5mg | 25mg | 25mg | 25mg |
| Pioglitazone hydrochloride(UNII: JQT35NPK6C) (Pioglitazone - UNII:X4OV71U42S) | Pioglitazone | 30mg | 15mg | 45mg | 30mg |
Inactive Ingredients
| Ingredient Name | Padagis Israel Pharmaceuticals Ltd |
|---|---|
| Alcohol(3K9958V90M) | |
| Butyl Alcohol(8PJ61P6TS3) | |
| Carnauba wax(R12CBM0EIZ) | |
| Croscarmellose sodium(M28OL1HH48) | |
| Ferric oxide Red(1K09F3G675) | |
| Ferric oxide yellow(EX438O2MRT) | |
| Ferrosoferric oxide(XM0M87F357) | |
| HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | |
| Hypromellose 2910 (6 MPA.S)(0WZ8WG20P6) | |
| Lactose Monohydrate(EWQ57Q8I5X) | |
| Magnesium stearate(70097M6I30) | |
| Mannitol(3OWL53L36A) | |
| Microcrystalline Cellulose(OP1R32D61U) | |
| Polyethylene Glycol 8000(Q662QK8M3B) | |
| Polyglyceryl-10 oleate(55C81W76DH) | |
| Shellac(46N107B71O) | |
| Talc(7SEV7J4R1U) | |
| Titanium dioxide(15FIX9V2JP) |
