USFDA APPLICATION NUMBER - 84612 / DOSAGE - TABLET;ORAL - 4MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DEXAMETHASONE(UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) | DEXAMETHASONE | 4mg |
Inactive Ingredients
Ingredient Name | Hikma Pharmaceuticals USA, Inc. | Fera Pharmaceuticals, LLC | Par Pharmaceutical Inc. | Pragma Pharmaceuticals, LLC | A-S Medication Solutions LLC | Lake Erie Medical DBA Quality Care Products LLC | REMEDYREPACK INC. |
---|---|---|---|---|---|---|---|
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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