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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209869
Company: BIOCON PHARMA

Products on ANDA 209869

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 209869

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209869Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/27/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/29/2021	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209869

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

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