USFDA APPLICATION NUMBER - 21411 / DOSAGE - CAPSULE;ORAL - EQ 80MG 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) |
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