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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078688


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NDA 078688 describes NADOLOL AND BENDROFLUMETHIAZIDE, which is a drug marketed by Impax Labs and Natco Pharma and is included in two NDAs. Additional details are available on the NADOLOL AND BENDROFLUMETHIAZIDE profile page.

The generic ingredient in NADOLOL AND BENDROFLUMETHIAZIDE is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 078688
Tradename:NADOLOL AND BENDROFLUMETHIAZIDE
Applicant:Natco Pharma
Ingredient:bendroflumethiazide; nadolol
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;40MG
Approval Date:Feb 15, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;80MG
Approval Date:Feb 15, 2008TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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