Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078735
Company: OXFORD PHARMS
Company: OXFORD PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| SIMVASTATIN | SIMVASTATIN | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/2010 | ORIG-1 | Approval |
Label is not available on this site. |
SIMVASTATIN
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 20MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |
| ZOCOR | SIMVASTATIN | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019766 | ORGANON |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078155 | ACCORD HLTHCARE |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077691 | AUROBINDO PHARMA |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078034 | BIOCON PHARMA |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077752 | DR REDDYS LABS INC |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 200895 | HETERO LABS LTD III |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 206557 | INVAGEN PHARMS |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078103 | LUPIN |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 090383 | MICRO LABS |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 078735 | OXFORD PHARMS |
| SIMVASTATIN | SIMVASTATIN | 80MG | TABLET;ORAL | Prescription | No | AB | 077837 | ZYDUS PHARMS USA |