Application 202805
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 125MG | No | No |
| 002 | GRISEOFULVIN, ULTRAMICROSIZE | GRISEOFULVIN, ULTRAMICROSIZE | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5827 | Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | Sandoz Inc | ANDA | Current |
| 0781-5827 | Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | Sandoz Inc | ANDA | Current |
| 0781-5828 | Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | Sandoz Inc | ANDA | Current |
| 0781-5828 | Ultramicrosize Griseofulvin | Ultramicrosize Griseofulvin | Sandoz Inc | ANDA | Current |