Levofloxacin
These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN.LEVOFLOXACIN oral solutionInitial U.S. Approval: 1996
Approved
Approval ID
7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2018
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levofloxacin
PRODUCT DETAILS
NDC Product Code17856-0286
Application NumberANDA091678
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 30, 2018
Generic NameLevofloxacin
INGREDIENTS (11)
LEVOFLOXACINActive
Quantity: 25 mg in 1 mL
Code: 6GNT3Y5LMF
Classification: ACTIM
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT