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Application 091038
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
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 |
|---|
| 64725-0552 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0554 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 64725-0555 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 70518-0026 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |