An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076341
Company: APOTEX

Products on ANDA 076341

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076341

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
02/18/2025	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
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-Package Insert, Labeling-Container/Carton Labels		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.

Therapeutic Equivalents for ANDA 076341

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

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	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	077491	SENORES 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

Top