USFDA APPLICATION NUMBER - 21447 / DOSAGE - CAPSULE;ORAL - EQ 6MG 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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