Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091476
Company: ANCHEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/13/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091476Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2015 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091482 ACTAVIS ELIZABETH
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091476 ANCHEN PHARMS
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203240 TORRENT

CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091482 ACTAVIS ELIZABETH
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091476 ANCHEN PHARMS
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203240 TORRENT

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