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Details for New Drug Application (NDA): 204841

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NDA 204841 describes SUMATRIPTAN, which is a drug marketed by Lannett, Teva Pharms Usa, Injectalia, Sagent Strides, Teva Parenteral, Antares Pharma Inc, Mylan Labs Ltd, Eurohlth Intl Sarl, Aurobindo Pharma, Par Pharm, Watson Labs, Fresenius Kabi Usa, Teva, Sagent Agila, Roxane, Mylan, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Sandoz, Par Sterile Products, Hikma Farmaceutica, Orchid Hlthcare, Wockhardt, Sun Pharm Inds, and Hikma Pharms, and is included in thirty-three 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-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for NDA: 204841

Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204841

Suppliers and Packaging for NDA: 204841

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

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

Summary for product number 002

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

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