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US Department of Justice
Colorcon
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Cerilliant
Baxter
Farmers Insurance
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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077833

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NDA 077833 describes NADOLOL AND BENDROFLUMETHIAZIDE, which is a drug marketed by Impax Labs and Mylan and is included in two NDAs. It is available from one supplier. 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. Two suppliers are listed for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 077833
Tradename:NADOLOL AND BENDROFLUMETHIAZIDE
Applicant:Impax Labs
Ingredient:bendroflumethiazide; nadolol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077833
Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 077833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 077833 ANDA Impax Generics 0115-5311 N 0115-5311-01
NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 077833 ANDA Impax Generics 0115-5311 N 0115-5311-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;40MG
Approval Date:Mar 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;80MG
Approval Date:Mar 30, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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