Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208130
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 06/29/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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 | COSETTE |
| 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 |
| 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 |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS 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 | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 5MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| 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 | 207135 | UMEDICA |
| 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 | COSETTE |
| 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 |
| 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 |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS 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 | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 20MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| 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 | 207135 | UMEDICA |
| 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 | COSETTE |
| 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 |
| 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 |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206227 | CHARTWELL RX |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 203281 | GLENMARK PHARMS 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 | 217399 | MSN |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 206720 | PRINSTON INC |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 210552 | QILU |
| 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 | 207135 | UMEDICA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 40MG | TABLET;ORAL | Prescription | No | AB | 205192 | ZYDUS PHARMS |