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Application 206155
- Type
- ANDA
- Sponsor
- INDOCO REMEDIES
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 |
|---|
| 14445-106 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 14445-107 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 14445-108 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 14445-109 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 14445-110 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 14445-111 | Olanzapine | Olanzapine | Indoco Remedies Limited | ANDA | Current |
| 51293-847 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-847 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-848 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-848 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-849 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-849 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-850 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-850 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-851 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-851 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-852 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |
| 51293-852 | Olanzapine | Olanzapine | ECI PHARMACEUTICALS LLC | ANDA | Current |