Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078034
Company: BIOCON PHARMA
Company: BIOCON PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/20/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/16/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2022 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2016 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/08/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2013 | SUPPL-6 | Labeling-Package Insert |
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 |