Details for New Drug Application (NDA): 207306

NDA 207306 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 sixteen suppliers. Additional details are available on the ARFORMOTEROL TARTRATE profile page.

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

Summary for 207306

Tradename:	ARFORMOTEROL TARTRATE
Applicant:	Cipla
Ingredient:	arformoterol tartrate
Patents:	0

Pharmacology for NDA: 207306

Mechanism of Action

Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 207306

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	207306	ANDA	Cipla USA Inc.	69097-168	69097-168-53	30 POUCH in 1 CARTON (69097-168-53) / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSE
ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	207306	ANDA	Cipla USA Inc.	69097-168	69097-168-64	12 POUCH in 1 CARTON (69097-168-64) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.015MG BASE/2ML
Approval Date:	Jun 22, 2021	TE:	AN	RLD:	No

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