Application 076133
- 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 | 15MG | No | No |
| 002 | 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 |
|---|
| 0093-5105 | Olanzapine | Olanzapine | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0615-7673 | Olanzapine | Olanzapine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6286 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6286 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6286 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6286 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6287 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6287 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6287 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 0904-6287 | Olanzapine | Olanzapine | Major Pharmaceuticals | ANDA | Current |
| 42254-206 | Olanzapine | Olanzapine | Rebel Distributors Corp | ANDA | Current |
| 55111-167 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-167 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-167 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-167 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-168 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-168 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-168 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-168 | Olanzapine | Olanzapine | Dr. Reddy's Laboratories Ltd. | ANDA | Current |
| 61786-005 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 63187-321 | Olanzapine | Olanzapine | Proficient Rx LP | ANDA | Current |
| 63187-329 | Olanzapine | Olanzapine | Proficient Rx LP | ANDA | Current |
| 68084-528 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-528 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-528 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-528 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-529 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-529 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-529 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 68084-529 | Olanzapine | Olanzapine | American Health Packaging | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0616 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1500 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1500 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1501 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1582 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1582 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1582 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1582 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1582 | Olanzapine | Olanzapine | REMEDYREPACK INC. | ANDA | Current |