Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206884
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/26/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206884Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMLODIPINE AND OLMESARTAN MEDOXOMIL
TABLET;ORAL; EQ 5MG BASE;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 5MG BASE;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207216 | AJANTA PHARMA LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207073 | ALEMBIC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209042 | ALKEM LABS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206906 | AUROBINDO PHARMA |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 206884 | MACLEODS PHARMS LTD |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207435 | MICRO LABS |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 209010 | SCIEGEN PHARMS INC |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | No | AB | 207771 | ZYDUS PHARMS |
| AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET;ORAL | Prescription | Yes | AB | 022100 | COSETTE |