Avelox
These highlights do not include all the information needed to use AVELOX safely and effectively. See full prescribing information for AVELOX.Initial U.S. Approval: 1999
Approved
Approval ID
fe9226f8-64f4-4eff-8339-ed3fce0896f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
moxifloxacin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0154
Application NumberNDA021085
Product Classification
M
Marketing Category
C73594
G
Generic Name
moxifloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2011
FDA Product Classification
INGREDIENTS (9)
MOXIFLOXACIN HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: C53598599T
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT