Details for New Drug Application (NDA): 211291

NDA 211291 describes RANOLAZINE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-four 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 211291

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

Pharmacology for NDA: 211291

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 211291

Cardiovascular Agents

Sodium Channel Blockers

Suppliers and Packaging for NDA: 211291

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211291	ANDA	Cipla USA Inc.	69097-221	69097-221-02	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-221-02)
RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211291	ANDA	Cipla USA Inc.	69097-221	69097-221-03	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-221-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	May 28, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	May 28, 2019	TE:		RLD:	No

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