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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 213465


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NDA 213465 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, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz, Somerset, 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 five 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-four suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 213465
Tradename:SUMATRIPTAN
Applicant:Padagis Israel
Ingredient:sumatriptan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213465
Medical Subject Heading (MeSH) Categories for 213465
Suppliers and Packaging for NDA: 213465
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN sumatriptan SPRAY;NASAL 213465 ANDA Padagis Israel Pharmaceuticals Ltd 45802-598 45802-598-06 6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00)
SUMATRIPTAN sumatriptan SPRAY;NASAL 213465 ANDA Padagis Israel Pharmaceuticals Ltd 45802-619 45802-619-06 6 CONTAINER in 1 CARTON (45802-619-06) / 1 SPRAY in 1 CONTAINER (45802-619-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength20MG/SPRAY
Approval Date:Sep 21, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Sep 21, 2020TE:ABRLD:No

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