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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 NDA: 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 0115-5311-01 100 TABLET in 1 BOTTLE (0115-5311-01)
NADOLOL AND BENDROFLUMETHIAZIDE
bendroflumethiazide; nadolol
TABLET;ORAL 077833 ANDA Impax Generics 0115-5311 0115-5311-02 500 TABLET in 1 BOTTLE (0115-5311-02)

Summary for product number 001

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

Summary for product number 002

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


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