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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203019

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NDA 203019 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, Chartwell Rx, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty 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 203019

Tradename:	ZOLMITRIPTAN
Applicant:	Zydus Pharms
Ingredient:	zolmitriptan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jul 11, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 11, 2018	TE:	AB	RLD:	No

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