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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212214

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NDA 212214 describes SOLIFENACIN SUCCINATE, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Bostal, Breckenridge, Chartwell Rx, Cipla, Glenmark Speclt, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, MSN, Novitium Pharma, Qilu, Rising, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-six NDAs. It is available from twenty-one suppliers. Additional details are available on the SOLIFENACIN SUCCINATE profile page.

The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.

Summary for 212214

Tradename:	SOLIFENACIN SUCCINATE
Applicant:	Novitium Pharma
Ingredient:	solifenacin succinate
Patents:	0

Medical Subject Heading (MeSH) Categories for 212214

Muscarinic Antagonists
Urological Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 26, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 26, 2019	TE:	AB	RLD:	No

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