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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 213085

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NDA 213085 describes RANOLAZINE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Arthur Grp, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Jubilant Generics, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Torrent, Unichem, and Vkt Pharma, and is included in twenty-six NDAs. It is available from twenty-seven suppliers. Additional details are available on the RANOLAZINE profile page.

The generic ingredient in RANOLAZINE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

Summary for 213085

Tradename:	RANOLAZINE
Applicant:	Piramal
Ingredient:	ranolazine
Patents:	0

Medical Subject Heading (MeSH) Categories for 213085

Cardiovascular Agents
Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jul 25, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Jul 25, 2023	TE:		RLD:	No

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