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Serving leading biopharmaceutical companies globally:

US Army
Citi
Express Scripts
Johnson and Johnson
Chubb
Harvard Business School
Healthtrust
Chinese Patent Office
Fuji
Queensland Health

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076130

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NDA 076130 describes VOSPIRE ER, which is a drug marketed by Dava Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the VOSPIRE ER profile page.

The generic ingredient in VOSPIRE ER is albuterol sulfate. There are thirty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for NDA: 076130

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076130

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 076130

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOSPIRE ER
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL 076130 ANDA DAVA Pharmaceuticals, Inc. 68774-400 68774-400-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68774-400-01)
VOSPIRE ER
albuterol sulfate
TABLET, EXTENDED RELEASE;ORAL 076130 ANDA DAVA Pharmaceuticals, Inc. 68774-401 68774-401-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68774-401-01)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Sep 26, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Sep 26, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
US Army
US Department of Justice
Johnson and Johnson
Fuji
Moodys
Dow
Teva
Novartis
Cantor Fitzgerald

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