
USFDA APPLICATION NUMBER - 50162 / DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| CLINDAMYCIN HYDROCHLORIDE(UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) | CLINDAMYCIN | 300mg | 150mg |
Inactive Ingredients
| Ingredient Name | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Direct Rx | Lannett Company, Inc. | NuCare Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals Inc. | RedPharm Drug, Inc. | REMEDYREPACK INC. | St. Mary's Medical Park Pharmacy | KAISER FOUNDATION HOSPITALS | Mylan Pharmaceuticals Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||
| AMMONIA(5138Q19F1X) | |||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | |||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||
| 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. 5(I753WB2F1M) | |||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||
| GELATIN(2G86QN327L) | |||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
| LACTOSE(J2B2A4N98G) | |||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||
| SHELLAC(46N107B71O) | |||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||
| TALC(7SEV7J4R1U) | |||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |