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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
McKesson
Daiichi Sankyo
Fish and Richardson
Covington
Novartis
Federal Trade Commission
Moodys
Cipla

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075664

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NDA 075664 describes ALBUTEROL SULFATE, which is a drug marketed by Mova, Vintage, Copley Pharm, Pliva, Apotex Inc, Warner Chilcott, Teva, Ucb Inc, Roxane, Watson Labs, Actavis Mid Atlantic, Sun Pharm Inds, Ritedose Corp, Amneal Pharms, Hi Tech Pharma, Teva Pharms, Am Therap, Bausch And Lomb, Sandoz, Mylan Speclt, G And W Labs Inc, Nephron, Sun Pharma Global, Dava Pharms Inc, Landela Pharm, Watson Labs Inc, Vistapharm, Mylan, Wockhardt Eu Operatn, Cipla Ltd, Watson Labs Teva, and Sandoz Inc, and is included in sixty-five NDAs. It is available from thirty-two suppliers. Additional details are available on the ALBUTEROL SULFATE profile page.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for NDA: 075664

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

Pharmacology for NDA: 075664

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 075664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION 075664 ANDA Nephron Pharmaceuticals Corporation 0487-9901 0487-9901-02 30 BAG in 1 BOX (0487-9901-02) > 1 POUCH in 1 BAG > 1 VIAL, SINGLE-DOSE in 1 POUCH > .5 mL in 1 VIAL, SINGLE-DOSE
ALBUTEROL SULFATE
albuterol sulfate
SOLUTION;INHALATION 075664 ANDA Nephron Pharmaceuticals Corporation 0487-9901 0487-9901-30 30 POUCH in 1 CARTON (0487-9901-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH > .5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.5% BASE
Approval Date:Jun 26, 2001TE:ANRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
Express Scripts
Chubb
McKinsey
Daiichi Sankyo
McKesson
AstraZeneca
Fish and Richardson
Medtronic
Fuji

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