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USFDA APPLICATION NUMBER - 20905 / DOSAGE - TABLET;ORAL - 20MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| LEFLUNOMIDE(UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W) | LEFLUNOMIDE | 20mg | 10mg |
Inactive Ingredients
| Ingredient Name | Golden State Medical Supply, Inc. | Prasco Laboratories | Zydus Lifesciences Limited | Zydus Pharmaceuticals (USA) Inc. | Avera McKennan Hospital | Bryant Ranch Prepack | NorthStar RxLLC | Trigen Laboratories, LLC |
|---|---|---|---|---|---|---|---|---|
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||
| CROSPOVIDONE(2S7830E561) | ||||||||
| CROSPOVIDONE(68401960MK) | ||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||
| POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | ||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||||
| POVIDONE K30(U725QWY32X) | ||||||||
| POVIDONE(FZ989GH94E) | ||||||||
| POVIDONES(FZ989GH94E) | ||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||
| TALC(7SEV7J4R1U) | ||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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