Product NDC: | 50383-587 |
Proprietary Name: | Nystatin |
Non Proprietary Name: | Nystatin |
Active Ingredient(s): | 100000 [USP'U]/mL & nbsp; Nystatin |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-587 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA064042 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120127 |
Package NDC: | 50383-587-66 |
Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (50383-587-66) > 60 mL in 1 BOTTLE, DROPPER |
NDC Code | 50383-587-66 |
Proprietary Name | Nystatin |
Package Description | 1 BOTTLE, DROPPER in 1 CARTON (50383-587-66) > 60 mL in 1 BOTTLE, DROPPER |
Product NDC | 50383-587 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Nystatin |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20120127 |
Marketing Category Name | ANDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | NYSTATIN |
Strength Number | 100000 |
Strength Unit | [USP'U]/mL |
Pharmaceutical Classes | Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] |