Product NDC: | 50383-024 |
Proprietary Name: | Ofloxacin |
Non Proprietary Name: | Ofloxacin |
Active Ingredient(s): | 3 mg/mL & nbsp; Ofloxacin |
Administration Route(s): | OPHTHALMIC |
Dosage Form(s): | SOLUTION/ DROPS |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-024 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076615 |
Marketing Category: | ANDA |
Start Marketing Date: | 20040514 |
Package NDC: | 50383-024-10 |
Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (50383-024-10) > 10 mL in 1 BOTTLE, DROPPER |
NDC Code | 50383-024-10 |
Proprietary Name | Ofloxacin |
Package Description | 1 BOTTLE, DROPPER in 1 CARTON (50383-024-10) > 10 mL in 1 BOTTLE, DROPPER |
Product NDC | 50383-024 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ofloxacin |
Dosage Form Name | SOLUTION/ DROPS |
Route Name | OPHTHALMIC |
Start Marketing Date | 20040514 |
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] |