| 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: | 44001-321-07 |
| Package Description: | 7 TABLET in 1 BLISTER PACK (44001-321-07) |
| NDC Code | 44001-321-07 |
| Proprietary Name | FACTIVE |
| Package Description | 7 TABLET in 1 BLISTER PACK (44001-321-07) |
| 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] |