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USFDA APPLICATION NUMBER - 21409 / DOSAGE - GRANULE;ORAL - EQ 4MG BASE/PACKET
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| MONTELUKAST SODIUM(UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E) | MONTELUKAST | 5mg |
Inactive Ingredients
| Ingredient Name | REMEDYREPACK INC. | Merck Sharp & Dohme Corp. | Mylan Pharmaceuticals Inc. | Teva Pharmaceuticals USA, Inc. | Prasco Laboratories | Torrent Pharmaceuticals Limited |
|---|---|---|---|---|---|---|
| ASPARTAME ACESULFAME(IFE6C6BS24) | ||||||
| aspartame(Z0H242BBR1) | ||||||
| CARNAUBA WAX(R12CBM0EIZ) | ||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||
| croscarmellose sodium(M28OL1HH48) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||
| ferric oxide red(1K09F3G675) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW) | ||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | ||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||
| magnesium stearate(70097M6I30) | ||||||
| MANNITOL HEXANITRATE(99AU28W1G9) | ||||||
| MANNITOL(3OWL53L36A) | ||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||
| POLYDEXTROSE(VH2XOU12IE) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| SODIUM PHOSPHATE, TRIBASIC(A752Q30A6X) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||
| TRIACETIN(XHX3C3X673) |
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