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Levofloxacin

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

Approved
Approval ID

fc165a6d-24b0-4753-a7ac-94a134dca0d3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 6, 2023

Manufacturers
FDA

Macleods Pharmaceuticals Limited

DUNS: 862128535

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Levofloxacin

PRODUCT DETAILS

NDC Product Code33342-532
Application NumberANDA200839
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 6, 2023
Generic NameLevofloxacin

INGREDIENTS (10)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LEVOFLOXACINActive
Quantity: 500 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

Levofloxacin

PRODUCT DETAILS

NDC Product Code33342-533
Application NumberANDA200839
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 6, 2023
Generic NameLevofloxacin

INGREDIENTS (8)

LEVOFLOXACINActive
Quantity: 750 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

Levofloxacin

PRODUCT DETAILS

NDC Product Code33342-531
Application NumberANDA200839
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 6, 2023
Generic NameLevofloxacin

INGREDIENTS (9)

LEVOFLOXACINActive
Quantity: 250 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
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Levofloxacin - FDA Approval | MedPath