Basic Information
Alprazolam
0228-4019
Regulatory Information
0228-4019
ANDA078561
C73584
December 20, 2022
USA
These highlights do not include all the information needed to use ALPRAZOLAM ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM ORALLY DISINTEGRATING TABLETS . ALPRAZOLAM orally disintegrating tablets, C-IV Initial U.S. Approval: 2005
HUMAN PRESCRIPTION DRUG LABEL
23
Company Information
119723554
Active Ingredients
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CROSPOVIDONE (15 MPA.S AT 5%)
Code: 68401960MK
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Code: NX76LV5T8J
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
SUCRALOSE
Code: 96K6UQ3ZD4
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
Active Moieties
ALPRAZOLAM
Code: YU55MQ3IZY