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Application 206763
- Type
- ANDA
- Sponsor
- ALKEM LABS 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 |
|---|
| 50090-3655 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3655 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3655 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3655 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3656 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3656 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3656 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 50090-3656 | Olmesartan Medoxomil | Olmesartan Medoxomil | A-S Medication Solutions | ANDA | Current |
| 67877-445 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-445 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-445 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-446 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-446 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-446 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-447 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-447 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-447 | Olmesartan Medoxomil | Olmesartan Medoxomil | Ascend Laboratories, LLC | ANDA | Current |
| 70518-1343 | Olmesartan Medoxomil | Olmesartan Medoxomil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1343 | Olmesartan Medoxomil | Olmesartan Medoxomil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1345 | Olmesartan Medoxomil | Olmesartan Medoxomil | REMEDYREPACK INC. | ANDA | Current |
| 70518-1345 | Olmesartan Medoxomil | Olmesartan Medoxomil | REMEDYREPACK INC. | ANDA | Current |
| 71205-458 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
| 71205-459 | Olmesartan Medoxomil | Olmesartan Medoxomil | Proficient Rx LP | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48113 | ORIG | 2017-04-26 |