Application 076255
- Type
- ANDA
- Sponsor
- DR REDDYS 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6283 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6283 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6283 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6376 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6376 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6376 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6377 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6377 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6377 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 43598-164 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-164 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-164 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-164 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-164 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-165 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-165 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-165 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-165 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-165 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-166 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-166 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-166 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-166 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-166 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 50090-3267 | Olanzapine | Olanzapine | A-S Medication Solutions | ANDA | Current |
| 50090-5047 | Olanzapine | Olanzapine | A-S Medication Solutions | ANDA | Current |
| 50090-5102 | Olanzapine | Olanzapine | A-S Medication Solutions | ANDA | Current |
| 55111-163 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-163 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-163 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-163 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55154-5877 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-5896 | Olanzapine | Olanzapine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5896 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-5896 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6878 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6881 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6881 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6881 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6881 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6881 | Olanzapine | Olanzapine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-6889 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6889 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6889 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6889 | Olanzapine | Olanzapine | Cardinal Health | ANDA | Current |
| 55154-6889 | Olanzapine | Olanzapine | Cardinal Health 107, LLC | ANDA | Current |
| 55700-927 | Olanzapine | Olanzapine | Quality Care Products, LLC | ANDA | Current |
| 55700-927 | Olanzapine | Olanzapine | Quality Care Products, LLC | ANDA | Current |
| 67296-1722 | Olanzapine | Olanzapine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1722 | Olanzapine | Olanzapine | RedPharm Drug, Inc. | ANDA | Current |
| 68084-525 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-525 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-525 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-525 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-525 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-723 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-723 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-723 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-723 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-723 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-740 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-740 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-740 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-740 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-740 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0110 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0615 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0615 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1535 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1535 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1535 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1535 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1535 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |