USFDA APPLICATION NUMBER - 22307 / DOSAGE - TABLET;ORAL - EQ 5MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
Prasugrel hydrochloride(UNII: G89JQ59I13) (Prasugrel - UNII:34K66TBT99) | Prasugrel | 10mg |
Inactive Ingredients
Ingredient Name | Cardinal Health | Lupin Pharmaceuticals, Inc. | A-S Medication Solutions | American Health Packaging | Apotex Corp. | Eli Lilly and Company
| Panacea Biotec Limited | Prasco Laboratories | Sunshine Lake Pharma Co., Ltd. | Unichem Pharmaceuticals (USA), Inc. |
---|---|---|---|---|---|---|---|---|---|---|
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||
DIETHYL PHTHALATE(UF064M00AF) | ||||||||||
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||||
FERRIC OXIDE RED(1K09F3G675) | ||||||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||||
GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR) | ||||||||||
GLYCERYL DIBEHENATE(R8WTH25YS2) | ||||||||||
HYDROCHLORIC ACID(QTT17582CB) | ||||||||||
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14) | ||||||||||
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | ||||||||||
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K) | ||||||||||
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | ||||||||||
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | ||||||||||
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
HYPROMELLOSES(3NXW29V3WO) | ||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||
LACTOSE(J2B2A4N98G) | ||||||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||||||||||
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(NZ94SDL6WR) | ||||||||||
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14) | ||||||||||
MANNITOL(3OWL53L36A) | ||||||||||
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y) | ||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||
STEARIC ACID(4ELV7Z65AP) | ||||||||||
SUCROSE STEARATE(274KW0O50M) | ||||||||||
TALC(7SEV7J4R1U) | ||||||||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||||
TRIACETIN(XHX3C3X673) |
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