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Julphar
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US Department of Justice
Fish and Richardson

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204841

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NDA 204841 describes SUMATRIPTAN, which is a drug marketed by Lannett Co Inc, Aurobindo Pharma Ltd, Antares Pharma Inc, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Apotex Inc, Aurobindo Pharma, Fosun Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-four NDAs. It is available from one supplier. Additional details are available on the SUMATRIPTAN profile page.

The generic ingredient in SUMATRIPTAN is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 204841
Tradename:SUMATRIPTAN
Applicant:Lannett Co Inc
Ingredient:sumatriptan
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204841
Medical Subject Heading (MeSH) Categories for 204841
Suppliers and Packaging for NDA: 204841
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN sumatriptan SPRAY;NASAL 204841 ANDA Lannett Company, Inc. 0527-1818 N 0527-1818-43
SUMATRIPTAN sumatriptan SPRAY;NASAL 204841 ANDA Lannett Company, Inc. 0527-1859 N 0527-1859-43

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Feb 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength20MG/SPRAY
Approval Date:Feb 19, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Deloitte
Accenture
Dow
Johnson and Johnson
Daiichi Sankyo
Medtronic
McKinsey
Argus Health

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