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USFDA APPLICATION NUMBER - 21777 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE(UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI) | CYCLOBENZAPRINE HYDROCHLORIDE | 15mg |
Inactive Ingredients
| Ingredient Name | TWi Pharmaceuticals, Inc. | A-S Medication Solutions | Amneal Pharmaceuticals of New York LLC | Apotex Corp. | Cephalon, LLC | Lake Erie Medical DBA Quality Care Products LLC | Physicians Total Care, Inc. | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
|---|---|---|---|---|---|---|---|---|
| ALCOHOL (3K9958V90M) | ||||||||
| ALCOHOL(3K9958V90M) | ||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||
| DIETHYL PHTHALATE(UF064M00AF) | ||||||||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | ||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | ||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||
| FERROSOFERRIC OXIDE (XM0M87F357) | ||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||
| GELATIN(2G86QN327L) | ||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||
| HYDROXYPROPYL CELLULOSE (1200000 WAMW) (U3JF91U133) | ||||||||
| HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133) | ||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||
| HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MPA.S)(6N003M473W) | ||||||||
| HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)(24P2YXD2PW) | ||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||
| METHYL ALCOHOL(Y4S76JWI15) | ||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||
| SHELLAC(46N107B71O) | ||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||
| SUCROSE(C151H8M554) | ||||||||
| titanium dioxide(15FIX9V2JP) |
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