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Details for New Drug Application (NDA): 200502

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NDA 200502 describes NARATRIPTAN, which is a drug marketed by Heritage Pharms Inc, Paddock Llc, Mylan Pharms Inc, Orchid Hlthcare, Teva Pharms, Sun Pharm Inds Ltd, Apotex Corp, Roxane, and Sandoz, and is included in nine NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for NDA: 200502

Heritage Pharms Inc
naratriptan hydrochloride
Therapeutic Class:Antimigraine Agents

Pharmacology for NDA: 200502

Suppliers and Packaging for NDA: 200502

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 28, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Feb 28, 2011TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.