Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076341
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | AB | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | AB | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 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 |
---|---|---|---|---|---|---|---|
10/23/2006 | 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 |
---|---|---|---|---|---|
04/26/2023 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2021 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
07/07/2017 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
07/12/2012 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/28/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/28/2007 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
PRAVASTATIN SODIUM
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 207068 | ACCORD HLTHCARE |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 077491 | APNAR PHARMA LP |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076341 | APOTEX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 203367 | AUROBINDO PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076056 | AUROBINDO PHARMA USA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 209869 | BIOCON PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 077917 | CHARTWELL RX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 077904 | CIPLA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076714 | DR REDDYS LABS INC |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 077987 | GLENMARK PHARMS LTD |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 076939 | WATSON LABS |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 207068 | ACCORD HLTHCARE |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077491 | APNAR PHARMA LP |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076341 | APOTEX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 203367 | AUROBINDO PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076056 | AUROBINDO PHARMA USA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 209869 | BIOCON PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077917 | CHARTWELL RX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077904 | CIPLA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076714 | DR REDDYS LABS INC |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077987 | GLENMARK PHARMS LTD |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 076939 | WATSON LABS |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Prescription | No | AB | 077751 | ZYDUS PHARMS USA |
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 207068 | ACCORD HLTHCARE |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077491 | APNAR PHARMA LP |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076341 | APOTEX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 203367 | AUROBINDO PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076056 | AUROBINDO PHARMA USA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 209869 | BIOCON PHARMA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077917 | CHARTWELL RX |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077904 | CIPLA |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076714 | DR REDDYS LABS INC |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077987 | GLENMARK PHARMS LTD |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 076939 | WATSON LABS |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Prescription | No | AB | 077751 | ZYDUS PHARMS USA |
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 | 077793 | AUROBINDO PHARMA USA |
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 | 076939 | WATSON LABS |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET;ORAL | Prescription | No | AB | 077751 | ZYDUS PHARMS USA |