FACTIVE - 10122-321-05 - (gemifloxacin mesylate)

Alphabetical Index


Drug Information of FACTIVE

Product NDC: 10122-321
Proprietary Name: FACTIVE
Non Proprietary Name: gemifloxacin mesylate
Active Ingredient(s): 320    mg/1 & nbsp;   gemifloxacin mesylate
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of FACTIVE

Product NDC: 10122-321
Labeler Name: Cornerstone Therapeutics Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021158
Marketing Category: NDA
Start Marketing Date: 20030404

Package Information of FACTIVE

Package NDC: 10122-321-05
Package Description: 5 TABLET in 1 BLISTER PACK (10122-321-05)

NDC Information of FACTIVE

NDC Code 10122-321-05
Proprietary Name FACTIVE
Package Description 5 TABLET in 1 BLISTER PACK (10122-321-05)
Product NDC 10122-321
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name gemifloxacin mesylate
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20030404
Marketing Category Name NDA
Labeler Name Cornerstone Therapeutics Inc.
Substance Name GEMIFLOXACIN MESYLATE
Strength Number 320
Strength Unit mg/1
Pharmaceutical Classes Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]

Complete Information of FACTIVE


General Information