Product NDC: | 44001-321 |
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) |
Product NDC: | 44001-321 |
Labeler Name: | Merus Labs International Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021158 |
Marketing Category: | NDA |
Start Marketing Date: | 20030404 |
Package NDC: | 44001-321-05 |
Package Description: | 5 TABLET in 1 BLISTER PACK (44001-321-05) |
NDC Code | 44001-321-05 |
Proprietary Name | FACTIVE |
Package Description | 5 TABLET in 1 BLISTER PACK (44001-321-05) |
Product NDC | 44001-321 |
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 | Merus Labs International Inc. |
Substance Name | GEMIFLOXACIN MESYLATE |
Strength Number | 320 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |