Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200082
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2020 | ORIG-1 | Approval |
Label is not available on this site. |
EZETIMIBE AND SIMVASTATIN
TABLET;ORAL; 10MG;10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 200082 | AUROBINDO PHARMA USA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | ORGANON |
TABLET;ORAL; 10MG;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 200082 | AUROBINDO PHARMA USA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | ORGANON |
TABLET;ORAL; 10MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 200082 | AUROBINDO PHARMA USA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | ORGANON |
TABLET;ORAL; 10MG;80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 209222 | ALKEM LABS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 208831 | AMNEAL PHARMS CO |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 200082 | AUROBINDO PHARMA USA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 200909 | DR REDDYS LABS SA |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 208699 | GLENMARK PHARMS LTD |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | No | AB | 202968 | WATSON LABS INC |
| VYTORIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;ORAL | Prescription | Yes | AB | 021687 | ORGANON |