Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091326
Company: PADDOCK LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB No No
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
07/08/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091326s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/05/2015 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

NARATRIPTAN

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 020763 GLAXOSMITHKLINE LLC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 200502 HERITAGE PHARMS INC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090381 HIKMA
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 091441 ORCHID HLTHCARE
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 091326 PADDOCK LLC

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
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 PADDOCK LLC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091552 SUN PHARM INDS LTD

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