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USFDA APPLICATION NUMBER - 22560 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 35MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| RISEDRONATE SODIUM HEMI-PENTAHYDRATE(UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z) | RISEDRONIC ACID | 30.1mg |
| RISEDRONATE SODIUM MONOHYDRATE(UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z) | RISEDRONIC ACID | 4.9mg |
Inactive Ingredients
| Ingredient Name | Actavis Pharma, Inc. | Teva Pharmaceuticals USA Inc |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
| EDETATE DISODIUM(7FLD91C86K) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLYSORBATE 80(6OZP39ZG8H) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||
| STEARIC ACID(4ELV7Z65AP) | ||
| TALC(7SEV7J4R1U) | ||
| TRIETHYL CITRATE(8Z96QXD6UM) |
