Details for New Drug Application (NDA): 212781

NDA 212781 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 212781

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

Pharmacology for NDA: 212781

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 212781

Cardiovascular Agents

Sodium Channel Blockers

Suppliers and Packaging for NDA: 212781

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	212781	ANDA	AvKARE	42291-773	42291-773-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-773-60)
RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	212781	ANDA	AvKARE	42291-774	42291-774-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-774-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Mar 23, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Mar 23, 2020	TE:	AB	RLD:	No

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