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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212469


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NDA 212469 describes ZOLMITRIPTAN, which is a drug marketed by Padagis Israel, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Ani Pharms, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the ZOLMITRIPTAN profile page.

The generic ingredient in ZOLMITRIPTAN is zolmitriptan. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.
Summary for 212469
Tradename:ZOLMITRIPTAN
Applicant:Padagis Israel
Ingredient:zolmitriptan
Patents:0
Pharmacology for NDA: 212469
Suppliers and Packaging for NDA: 212469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLMITRIPTAN zolmitriptan SPRAY;NASAL 212469 ANDA Padagis Israel Pharmaceuticals Ltd 45802-711 45802-711-91 6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)
ZOLMITRIPTAN zolmitriptan SPRAY;NASAL 212469 ANDA Bryant Ranch Prepack 63629-9575 63629-9575-1 6 BOTTLE, SPRAY in 1 CARTON (63629-9575-1) / 1 SPRAY in 1 BOTTLE, SPRAY (63629-9575-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength2.5MG/SPRAY
Approval Date:Sep 30, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Sep 30, 2021TE:ABRLD:No

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