Application 202050
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA 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 |
|---|
| 35573-422 | OLANZAPINE | olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-423 | OLANZAPINE | olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-424 | OLANZAPINE | Olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-425 | OLANZAPINE | Olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-426 | OLANZAPINE | Olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-427 | OLANZAPINE | olanzapine | Burel Pharmaceuticals, LLC | ANDA | Current |
| 52343-038 | OLANZAPINE | olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-038 | OLANZAPINE | olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-039 | OLANZAPINE | olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-039 | OLANZAPINE | olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-040 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-040 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-041 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-041 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-042 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-042 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-043 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-043 | OLANZAPINE | Olanzapine | ACETRIS HEALTH, LLC | ANDA | Current |
| 65862-561 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-561 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-561 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-561 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-561 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-562 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-562 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-562 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-562 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-562 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-563 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-563 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-563 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-563 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-563 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-564 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-564 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-564 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-564 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-564 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-565 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-565 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-565 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-565 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-565 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-566 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-566 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-566 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-566 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-566 | Olanzapine | Olanzapine | Aurobindo Pharma Limited | ANDA | Current |
| 66993-680 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-680 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-680 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-680 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-681 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-681 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-681 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-681 | OLANZAPINE | olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-682 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-682 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-682 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-682 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-683 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-683 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-683 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-683 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-684 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-684 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-684 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-684 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-685 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-685 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-685 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 66993-685 | OLANZAPINE | Olanzapine | Prasco Laboratories | ANDA | Current |
| 68788-8185 | Olanzapine | Olanzapine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2158 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2158 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2891 | OLANZAPINE | olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2891 | OLANZAPINE | olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3054 | OLANZAPINE | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 71335-1936 | Olanzapine | Olanzapine | Bryant Ranch Prepack | ANDA | Current |