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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090381
Company: HIKMA

Products on ANDA 090381

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090381

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090381s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/14/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/11/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090381

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
NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	200502	HERITAGE
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	ORBION PHARMS

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
NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	200502	HERITAGE
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	ORBION PHARMS

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