Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077793
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/15/2008 | 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 |
|---|---|---|---|---|---|
| 03/20/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/11/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-1 | Labeling |
Label is not available on this site. |
PRAVASTATIN SODIUM
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 207068 | ACCORD HLTHCARE |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077491 | APNAR PHARMA LP |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 076341 | APOTEX |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 203367 | AUROBINDO PHARMA |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 209869 | BIOCON PHARMA |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077917 | CHARTWELL RX |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077904 | CIPLA |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 076714 | DR REDDYS LABS INC |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077987 | GLENMARK PHARMS LTD |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077793 | TEVA PHARMS |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 076939 | WATSON LABS |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077751 | ZYDUS PHARMS USA |