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Generated: November 15, 2018

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Details for New Drug Application (NDA): 091326

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NDA 091326 describes NARATRIPTAN, which is a drug marketed by Apotex Corp, Casi Pharms Inc, Heritage Pharms Inc, Mylan Pharms Inc, Orchid Hlthcare, Paddock Llc, Sun Pharm Inds Ltd, Teva Pharms, and West-ward Pharms Int, and is included in nine NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for 091326
Applicant:Paddock Llc
Ingredient:naratriptan hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 091326
Suppliers and Packaging for NDA: 091326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 091326 ANDA Paddock Laboratories, LLC 0574-0214 0574-0214-09 9 BLISTER PACK in 1 CARTON (0574-0214-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jul 8, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 8, 2010TE:ABRLD:No

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