Last Updated: October 16, 2026

Details for New Drug Application (NDA): 220118

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NDA 220118 describes NINTEDANIB ESYLATE, which is a drug marketed by Apotex, Biocon Pharma, Cipla, Dexcel, Dr Reddys, Glenmark Pharms Ltd, Humanwell Puracap, Macleods Pharms, and Sandoz, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the NINTEDANIB ESYLATE profile page.

The generic ingredient in NINTEDANIB ESYLATE is nintedanib esylate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nintedanib esylate profile page.

Summary for 220118

Tradename:	NINTEDANIB ESYLATE
Applicant:	Biocon Pharma
Ingredient:	nintedanib esylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Aug 19, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 19, 2026	TE:	AB	RLD:	No

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