FACTIVE
FACTIVE (gemifloxacin mesylate) Tablets
Approved
Approval ID
63f60426-e27f-4258-9bfc-b4a15ebdca83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2016
Manufacturers
FDA
Merus Labs International Inc.
DUNS: 244172404
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gemifloxacin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44001-321
Application NumberNDA021158
Product Classification
M
Marketing Category
C73594
G
Generic Name
gemifloxacin mesylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2016
FDA Product Classification
INGREDIENTS (10)
GEMIFLOXACIN MESYLATEActive
Quantity: 320 mg in 1 1
Code: X4S9F8RL01
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT