Last Updated: November 7, 2026

Details for New Drug Application (NDA): 091200

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NDA 091200 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Ph Health, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt Bio Ag, Yiling, and Yung Shin Pharm, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the FELODIPINE profile page.

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

Summary for 091200

Tradename:	FELODIPINE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	felodipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 091200

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:	Dec 13, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Dec 13, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Dec 13, 2013	TE:	AB	RLD:	No

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