
USFDA APPLICATION NUMBER - 21411 / DOSAGE - CAPSULE;ORAL - EQ 25MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) | ATOMOXETINE HYDROCHLORIDE | 18mg |
Inactive Ingredients
| Ingredient Name | Glenmark Pharmaceuticals Inc., USA | REMEDYREPACK INC. | Zydus Pharmaceuticals USA Inc. | Teva Pharmaceuticals USA, Inc. | Zydus Lifesciences Limited | American Health Packaging | Aurobindo Pharma Limited | Avera McKennan Hospital | Cardinal Health | Lake Erie Medical DBA Quality Care Products LLC | Prasco Laboratories | REMEDYREPACK INC. | Rising Pharma Holdings, Inc. | Apotex Corp. | Golden State Medical Supply, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||||||
| AMMONIA(5138Q19F1X) | |||||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | |||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||
| DIMETHICONE(92RU3N3Y1O) | |||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | |||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||||||
| METHYL ALCOHOL(Y4S76JWI15) | |||||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
| sodium lauryl sulfate(368GB5141J) | |||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||||||
| WATER(059QF0KO0R) |