Details for New Drug Application (NDA): 021912

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NDA 021912 describes BROVANA, which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. Additional details are available on the BROVANA profile page.

The generic ingredient in BROVANA 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 021912

Tradename:	BROVANA
Applicant:	Lupin
Ingredient:	arformoterol tartrate
Patents:	0

Pharmacology for NDA: 021912

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 021912

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-060	27437-060-30	30 POUCH in 1 CARTON (27437-060-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912	NDA	Lupin Pharmaceuticals, Inc.	27437-060	27437-060-60	60 POUCH in 1 CARTON (27437-060-60) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.015MG BASE/2ML
Approval Date:	Oct 6, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021912

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,720,453	⤷ Get Started Free
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,541,385	⤷ Get Started Free
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,462,645	⤷ Get Started Free
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	5,795,564	⤷ Get Started Free
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,814,953	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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