| Product NDC: | 0168-0037 |
| 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: | 0168-0037 |
| Labeler Name: | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA062517 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19840607 |
| Package NDC: | 0168-0037-60 |
| Package Description: | 1 BOTTLE in 1 CARTON (0168-0037-60) > 60 mL in 1 BOTTLE |
| NDC Code | 0168-0037-60 |
| Proprietary Name | nystatin |
| Package Description | 1 BOTTLE in 1 CARTON (0168-0037-60) > 60 mL in 1 BOTTLE |
| Product NDC | 0168-0037 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | nystatin |
| Dosage Form Name | SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 19840607 |
| Marketing Category Name | ANDA |
| Labeler Name | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Substance Name | NYSTATIN |
| Strength Number | 100000 |
| Strength Unit | [USP'U]/mL |
| Pharmaceutical Classes | Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] |