Application 065203
- Type
- ANDA
- Sponsor
- MAYNE PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYSTATIN | NYSTATIN | POWDER;TOPICAL | 100,000 UNITS/GM | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-769 | Nystatin | Nystatin | NorthStar Rx LLC | ANDA | Current |
| 16714-769 | Nystatin | Nystatin | NorthStar Rx LLC | ANDA | Current |
| 42254-303 | Nystatin | Nystatin | Rebel Distributors Corp | ANDA | Current |
| 68308-152 | Nystatin | Nystatin | Mayne Pharma Inc. | ANDA | Current |
| 68308-152 | Nystatin | Nystatin | Mayne Pharma Inc. | ANDA | Current |
| 68308-152 | Nystatin | Nystatin | Mayne Pharma Inc. | ANDA | Current |
| 68308-152 | Nystatin | Nystatin | Mayne Pharma Inc. | ANDA | Current |
| 76519-1007 | Nystatin | Nystatin | H.J. Harkins Company, Inc. | ANDA | Current |