Product NDC: | 50383-025 |
Proprietary Name: | Ofloxacin |
Non Proprietary Name: | Ofloxaxin |
Active Ingredient(s): | 3 mg/mL & nbsp; Ofloxaxin |
Administration Route(s): | AURICULAR (OTIC) |
Dosage Form(s): | SOLUTION/ DROPS |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-025 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076616 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080317 |
Package NDC: | 50383-025-05 |
Package Description: | 1 BOTTLE in 1 CARTON (50383-025-05) > 5 mL in 1 BOTTLE |
NDC Code | 50383-025-05 |
Proprietary Name | Ofloxacin |
Package Description | 1 BOTTLE in 1 CARTON (50383-025-05) > 5 mL in 1 BOTTLE |
Product NDC | 50383-025 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ofloxaxin |
Dosage Form Name | SOLUTION/ DROPS |
Route Name | AURICULAR (OTIC) |
Start Marketing Date | 20080317 |
Marketing Category Name | ANDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | OFLOXACIN |
Strength Number | 3 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] |