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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-0286
Application NumberANDA091678
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2018
FDA Product Classification

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

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Levofloxacin - FDA Drug Approval Details