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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 204841


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NDA 204841 describes SUMATRIPTAN, which is a drug marketed by Cipla, Florida, Lannett Co Inc, Padagis Israel, Aurobindo Pharma Ltd, Rising, Sun Pharm, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-one NDAs. It is available from six suppliers. 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. Thirty-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
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 0527-1818-43 6 BLISTER PACK in 1 CARTON (0527-1818-43) / .1 mL in 1 BLISTER PACK
SUMATRIPTAN sumatriptan SPRAY;NASAL 204841 ANDA Lannett Company, Inc. 0527-1859 0527-1859-43 6 BLISTER PACK in 1 CARTON (0527-1859-43) / .1 mL in 1 BLISTER PACK

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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