Application 203044
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-083 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-083 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-083 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-083 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-083 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-084 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-084 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-084 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-084 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-084 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-085 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-085 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-085 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-085 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-085 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-086 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-086 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-086 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-086 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-086 | Olanzapine | Olanzapine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 70518-0144 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0144 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0144 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0145 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0145 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0145 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0148 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0148 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0148 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0149 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0149 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0149 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |