Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090595
Company: MYLAN PHARMS INC
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
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
03/26/2013 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

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

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