Application 204798
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | TABLET;ORAL | 5MG | No | No |
| 002 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | TABLET;ORAL | 20MG | No | No |
| 003 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-741 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-742 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-743 | Olmesartan Medoxomil | Olmesartan Medoxomil | Aurobindo Pharma Limited | ANDA | Current |
| 71205-172 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
| 71205-172 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
| 71205-174 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
| 71205-174 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
| 71335-1074 | Olmesartan Medoxomil | Olmesartan Medoxomil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1074 | Olmesartan Medoxomil | Olmesartan Medoxomil | Bryant Ranch Prepack | ANDA | Current |