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Last Updated: March 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074302


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NDA 074302 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 Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco, Arise, Dava Pharms Inc, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Cipla, Fosun Pharma, and Watson Labs Teva, and is included in seventy-one 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-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 074302
Tradename:ALBUTEROL SULFATE
Applicant:Mova
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML
Approval Date:Sep 30, 1994TE:RLD:No

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