Application 062517
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYSTATIN | NYSTATIN | SUSPENSION;ORAL | 100,000 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0037 | nystatin | nystatin | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |