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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074749

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NDA 074749 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-three 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 074749

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

Pharmacology for NDA: 074749

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 074749

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074749 ANDA Atlantic Biologicals Corps 17856-0740 17856-0740-3 5 mL in 1 CUP (17856-0740-3)
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074749 ANDA Rebel Distributors Corp 21695-350 21695-350-16 473 mL in 1 BOTTLE (21695-350-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML
Approval Date:Jan 30, 1998TE:AARLD:No


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