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Application 202295
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 2.5MG | No | No |
| 002 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 5MG | No | No |
| 003 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 7.5MG | No | No |
| 004 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 10MG | No | No |
| 005 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 15MG | No | No |
| 006 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-172 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-172 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-173 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-173 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-174 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-174 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-175 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-175 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-176 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-176 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-177 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-177 | Olanzapine | Olanzapine | Ascend Laboratories, LLC | ANDA | Current |