Application 208146
- Type
- ANDA
- Sponsor
- HEC PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
| 002 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
| 003 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
| 004 | OLANZAPINE | OLANZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7855 | Olanzapine | Olanzapine | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7856 | Olanzapine | Olanzapine | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7857 | Olanzapine | Olanzapine | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7858 | Olanzapine | Olanzapine | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |