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USFDA APPLICATION NUMBER - 22512 / DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE(UNII: SC7NUW5IIT) (DABIGATRAN - UNII:I0VM4M70GC) | DABIGATRAN | 150mg |
Inactive Ingredients
| Ingredient Name | Ascend Laboratories, LLC |
|---|---|
| AMMONIA(5138Q19F1X) | |
| BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FD&C YELLOW NO. 6(H77VEI93A8) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | |
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR) | |
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| POLYETHYLENE GLYCOL 600(NL4J9F21N9) | |
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |
| POVIDONE K25(K0KQV10C35) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| SHELLAC(46N107B71O) | |
| SODIUM BICARBONATE(8MDF5V39QO) | |
| TALC(7SEV7J4R1U) | |
| TARTARIC ACID(W4888I119H) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |
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