Details for New Drug Application (NDA): 200502

NDA 200502 describes NARATRIPTAN, which is a drug marketed by Ani Pharms, Apotex Corp, Aurobindo Pharma Usa, Chartwell Rx, Heritage, Hikma, Orbion Pharms, Padagis Us, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from four suppliers. Additional details are available on the NARATRIPTAN profile page.

The generic ingredient in NARATRIPTAN is naratriptan hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for 200502

Tradename:	NARATRIPTAN
Applicant:	Heritage
Ingredient:	naratriptan hydrochloride
Patents:	0

Pharmacology for NDA: 200502

Mechanism of Action

Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 200502

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NARATRIPTAN	naratriptan hydrochloride	TABLET;ORAL	200502	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-054	23155-054-03	30 TABLET in 1 BOTTLE (23155-054-03)
NARATRIPTAN	naratriptan hydrochloride	TABLET;ORAL	200502	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-054	23155-054-05	500 TABLET in 1 BOTTLE (23155-054-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Feb 28, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Feb 28, 2011	TE:	AB	RLD:	No

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