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USFDA APPLICATION NUMBER - 21179 / DOSAGE - TABLET;ORAL - 400MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| SEVELAMER HYDROCHLORIDE(UNII: GLS2PGI8QG) (SEVELAMER - UNII:941N5DUU5C) | SEVELAMER HYDROCHLORIDE | 800mg | 400mg |
Inactive Ingredients
| Ingredient Name | Glenmark Pharmaceuticals Inc., USA | NorthStar RxLLC | Cardinal Health | Lupin Pharmaceuticals, Inc. |
|---|---|---|---|---|
| AMMONIA(5138Q19F1X) | ||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||
| DIACETYLATED MONOGLYCERIDES(5Z17386USF) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | ||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||
| HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
| MANNITOL(3OWL53L36A) | ||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | ||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||
| SHELLAC(46N107B71O) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| STEARIC ACID(4ELV7Z65AP) | ||||
| TALC(7SEV7J4R1U) | ||||
| WATER(059QF0KO0R) | ||||
| ZINC STEARATE(H92E6QA4FV) |
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