Application 077376
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | No | No |
| 004 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55154-8335 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 55154-8335 | Mirtazapine | Mirtazapine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8335 | Mirtazapine | Mirtazapine | Cardinal Health | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-011 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-012 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 57237-013 | Mirtazapine | Mirtazapine | Rising Health, LLC | ANDA | Current |
| 63629-5085 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5086 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5086 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5086 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5275 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5537 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5537 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-5537 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-021 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-022 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-023 | Mirtazapine | Mirtazapine | Aurobindo Pharma Limited | ANDA | Current |
| 71335-0717 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0717 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0717 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1534 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1534 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 44350 | ORIG | 2006-03-09 |