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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219819
Company: DEXCEL

Products on ANDA 219819

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219819

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219819

NINTEDANIB ESYLATE

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	219227	APOTEX
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	212609	CIPLA
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	219819	DEXCEL
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	219283	DR REDDYS
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	216915	SANDOZ
OFEV	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	205832	BOEHRINGER INGELHEIM

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	219227	APOTEX
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	212609	CIPLA
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	219819	DEXCEL
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	219283	DR REDDYS
NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	216915	SANDOZ
OFEV	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	205832	BOEHRINGER INGELHEIM

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