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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074880

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NDA 074880 describes ALBUTEROL SULFATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, G And W Labs Inc, Mova, Teva, Vintage, Vistapharm, Mylan, Am Therap, Dava Pharms Inc, Pliva, Sandoz, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Cipla Ltd, Sandoz Inc, and Watson Labs Teva, and is included in sixty-six NDAs. It is available from thirty-four 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 074880

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

Pharmacology for NDA: 074880

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 074880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074880 ANDA Nephron SC Inc. 0487-9501 0487-9501-03 1 POUCH in 1 CARTON (0487-9501-03) > 30 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074880 ANDA Nephron SC Inc. 0487-9501 0487-9501-01 30 POUCH in 1 CARTON (0487-9501-01) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.083% BASE
Approval Date:Sep 17, 1997TE:ANRLD:No


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McKesson
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Harvard Business School
Baxter

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