Application 064042
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
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 |
|---|---|---|---|---|---|
| 42254-322 | Nystatin | Nystatin | Rebel Distributors Corp | ANDA | Current |
| 50090-3257 | Nystatin | Nystatin | A-S Medication Solutions | ANDA | Current |
| 50383-587 | Nystatin | Nystatin | Akorn | ANDA | Current |
| 50383-587 | Nystatin | Nystatin | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-587 | Nystatin | Nystatin | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |