Basic Information
Levofloxacin
82982-034
Regulatory Information
82982-034
ANDA202801
C73584
March 29, 2023
USA
LEVOFLOXACIN TABLETS. These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
118772692
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
Active Moieties
LEVOFLOXACIN ANHYDROUS
Code: RIX4E89Y14