Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216303

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NDA 216303 describes ARFORMOTEROL TARTRATE, which is a drug marketed by Aiping Pharm Inc, Alembic, Aucta, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Neocubes Pharma, Ritedose Corp, Saba Ilac Sanayi, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in seventeen NDAs. It is available from fifteen suppliers. Additional details are available on the ARFORMOTEROL TARTRATE profile page.

The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.

Summary for 216303

Tradename:	ARFORMOTEROL TARTRATE
Applicant:	Neocubes Pharma
Ingredient:	arformoterol tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.015MG BASE/2ML
Approval Date:	May 17, 2024	TE:	AN	RLD:	No

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