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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-six 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:
VOSPIRE ER
Applicant:
Dava Pharms Inc
Ingredient:
albuterol sulfate
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:Yes


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