Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091552
Company: SUN PHARM INDS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;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
02/14/2011 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
09/22/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
08/30/2013 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

NARATRIPTAN

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 020763 GLAXOSMITHKLINE LLC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 200502 HERITAGE PHARMS INC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 090381 HIKMA PHARMS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091441 ORCHID HLTHCARE
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091326 PADAGIS US
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091552 SUN PHARM INDS LTD

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