USFDA APPLICATION NUMBER - 84611 / DOSAGE - TABLET;ORAL - 0.5MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DEXAMETHASONE(UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) | DEXAMETHASONE | 0.5mg | 0.75mg | 1mg | 1.5mg | 2mg | 4mg | 6mg | 1mg in 1 | 0.5mg in 5 | 0.5mg | 0.75mg | 1mg | 6mg | 2mg | 4mg | 1.5mg |
Inactive Ingredients
Ingredient Name | Hikma Pharmaceuticals USA, Inc. | Fera Pharmaceuticals, LLC | Par Pharmaceutical Inc. | Pragma Pharmaceuticals, LLC |
---|---|---|---|---|
ALCOHOL(3K9958V90M) | ||||
anhydrous lactose(3SY5LH9PMK) | ||||
BENZOIC ACID(8SKN0B0MIM) | ||||
CHERRY(BUC5I9595W) | ||||
CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||||
croscarmellose sodium(M28OL1HH48) | ||||
D&C Yellow No. 10(35SW5USQ3G) | ||||
EDETATE DISODIUM(7FLD91C86K) | ||||
FD&C BLUE NO. 1(H3R47K3TBD) | ||||
FD&C GREEN NO. 3(3P3ONR6O1S) | ||||
FD&C RED NO. 3(PN2ZH5LOQY) | ||||
FD&C RED NO. 40(WZB9127XOA) | ||||
FD&C YELLOW NO. 5(I753WB2F1M) | ||||
FD&C YELLOW NO. 6(H77VEI93A8) | ||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
GLYCERIN(PDC6A3C0OX) | ||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
MAGNESIUM STEARATE(70097M6I30) | ||||
METHYLPARABEN(A2I8C7HI9T) | ||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
PROPYLENE GLYCOL(6DC9Q167V3) | ||||
PROPYLPARABEN(Z8IX2SC1OH) | ||||
SORBITOL(506T60A25R) | ||||
STARCH, CORN(O8232NY3SJ) | ||||
stearic acid(4ELV7Z65AP) | ||||
SUCROSE(C151H8M554) | ||||
WATER(059QF0KO0R) |
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