Application 064118
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NYSTOP | NYSTATIN | POWDER;TOPICAL | 100,000 UNITS/GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-2008 | Nystop | Nystatin | Padagis US LLC | ANDA | Current |
| 0574-2008 | Nystop | Nystatin | Paddock Laboratories, LLC | ANDA | Current |
| 63629-8696 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8696 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8696 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8697 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8697 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8697 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8698 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8698 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8698 | Nystop | Nystatin | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42780 | ORIG | 2005-07-22 |