Application 076534
- 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, 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 |
|---|
| 50090-2827 | Olanzapine | Olanzapine | A-S Medication Solutions | ANDA | Current |
| 55111-262 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-262 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-262 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-262 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-262 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-263 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-263 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-263 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-263 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-263 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-264 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-264 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-264 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-264 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-264 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-265 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-265 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-265 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-265 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-265 | Olanzapine | Olanzapine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 64725-0265 | Olanzapine | Olanzapine | TYA Pharmaceuticals | ANDA | Current |
| 71335-0663 | Olanzapine | Olanzapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0663 | Olanzapine | Olanzapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0663 | Olanzapine | Olanzapine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8922 | ORIG | 2011-10-31 |