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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 203032

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NDA 203032 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Endo Operations, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt, Yiling, and Yung Shin Pharm, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the FELODIPINE profile page.

The generic ingredient in FELODIPINE is felodipine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.

Summary for 203032

Tradename:	FELODIPINE
Applicant:	Orbion Pharms
Ingredient:	felodipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 203032

Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	2.5MG
Approval Date:	May 21, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	May 21, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	May 21, 2015	TE:	AB	RLD:	No

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