Application 212739
- Type
- ANDA
- Sponsor
- SUNSHINE LAKE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 30MG BASE | No | No |
| 002 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 45MG BASE | No | No |
| 003 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7899 | Oseltamivir Phosphate | oseltamivir phosphate | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7900 | Oseltamivir Phosphate | oseltamivir phosphate | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7901 | Oseltamivir Phosphate | oseltamivir phosphate | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |