Drugs@FDA: FDA-Approved Drugs
Company: TEVA
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/24/2006 | 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 |
---|---|---|---|---|---|
02/16/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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01/23/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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02/05/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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12/30/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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05/04/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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01/08/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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10/05/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/16/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/27/2006 | SUPPL-2 | Labeling |
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 | 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 | 076056 | TEVA |
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 | 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 | 076056 | TEVA |
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 | 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 | 076056 | TEVA |
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 |