Application 204320
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|
| 27241-025 | olanzapine | olanzapine | Ajanta Pharma Limited | ANDA | Current |
| 27241-026 | olanzapine | olanzapine | Ajanta Pharma Limited | ANDA | Current |
| 27241-027 | olanzapine | olanzapine | Ajanta Pharma Limited | ANDA | Current |
| 27241-028 | olanzapine | olanzapine | Ajanta Pharma Limited | ANDA | Current |