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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076056
Company: AUROBINDO PHARMA USA

Products on ANDA 076056

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076056

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
02/24/2025	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
02/16/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
01/23/2017	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/30/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/05/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/30/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/04/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/08/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/05/2007	SUPPL-7	Labeling		Label is not available on this site.
03/16/2007	SUPPL-5	Labeling		Label is not available on this site.
09/27/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076056

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	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	077491	SENORES PHARMS
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	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	077491	SENORES PHARMS
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	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	077491	SENORES PHARMS
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

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