Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209397
Company: BEIJING

Products on ANDA 209397

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209397

FLUVASTATIN SODIUM

TABLET, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209397	BEIJING
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	079011	TEVA PHARMS USA
LESCOL XL	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021192	SANDOZ