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USFDA APPLICATION NUMBER - 21447 / DOSAGE - CAPSULE;ORAL - EQ 4MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| tizanidine hydrochloride(UNII: B53E3NMY5C) (tizanidine - UNII:6AI06C00GW) | tizanidine | 6mg | 4mg | 2mg |
Inactive Ingredients
| Ingredient Name | Mylan Pharmaceuticals Inc. | Acorda Therapeutics, Inc. | SA3, LLC | Quality Care Products, LLC | Clinical Solutions Wholesale | Par Pharmaceutical, Inc. | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
|---|---|---|---|---|---|---|---|
| AMMONIA(5138Q19F1X) | |||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||
| ETHYL ACRYLATE(71E6178C9T) | |||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | |||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||
| GELATIN(2G86QN327L) | |||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||
| METHACRYLIC ACID(1CS02G8656) | |||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||
| SHELLAC(46N107B71O) | |||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||
| STARCH, CORN(O8232NY3SJ) | |||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||
| SUCROSE(C151H8M554) | |||||||
| TALC(7SEV7J4R1U) | |||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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