Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090595
Company: MYLAN PHARMS INC

Products on ANDA 090595

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090595

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2012	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
09/25/2020	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/15/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/26/2013	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090595

FLUVASTATIN SODIUM

CAPSULE;ORAL; EQ 20MG 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 20MG BASE	CAPSULE;ORAL	Prescription	No	AB	090595	MYLAN PHARMS INC
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB	078407	TEVA PHARMS

CAPSULE;ORAL; EQ 40MG 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 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	090595	MYLAN PHARMS INC
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	078407	TEVA PHARMS