Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078276
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078276Orig1s000ltr.pdf |
OLMESARTAN MEDOXOMIL
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | DAIICHI SANKYO |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206631 | LUPIN LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 078276 | MYLAN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 090237 | SANDOZ INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 202375 | TORRENT |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA LABS PVT LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | DAIICHI SANKYO |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206631 | LUPIN LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 078276 | MYLAN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 090237 | SANDOZ INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 202375 | TORRENT |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA LABS PVT LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENICAR | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021286 | DAIICHI SANKYO |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 207662 | ACCORD HLTHCARE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 203012 | ALEMBIC PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206763 | ALKEM LABS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 204798 | AUROBINDO PHARMA LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206631 | LUPIN LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 204814 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206372 | MICRO LABS |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 078276 | MYLAN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 090237 | SANDOZ INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 208130 | SCIEGEN PHARMS INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 211049 | SUNSHINE |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 202375 | TORRENT |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 207135 | UMEDICA LABS PVT LTD |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |
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