Application 206884
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;20MG | No | No |
| 002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;20MG | No | No |
| 003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;40MG | No | No |
| 004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-190 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-190 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-190 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-191 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-191 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-191 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-192 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-192 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-192 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-193 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-193 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-193 | AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE and OLMESARTAN medoxomil | Macleods Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45699 | ORIG | 2016-10-28 |