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Serving leading biopharmaceutical companies globally:

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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075579

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NDA 075579 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Elizabeth, Apothecon, Ivax Sub Teva Pharms, Mylan, Sandoz, Teva, Unichem, and Watson Labs Teva, and is included in nine NDAs. It is available from thirteen suppliers. Additional details are available on the BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 075579
Tradename:BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Applicant:Sandoz
Ingredient:bisoprolol fumarate; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075579
Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 075579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075579 ANDA Eon Labs, Inc. 0185-0701 0185-0701-05 500 TABLET, COATED in 1 BOTTLE (0185-0701-05)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 075579 ANDA Eon Labs, Inc. 0185-0701 0185-0701-30 30 TABLET, COATED in 1 BOTTLE (0185-0701-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;6.25MG
Approval Date:Sep 25, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Sep 25, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;6.25MG
Approval Date:Sep 25, 2000TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Deloitte
Julphar
Merck
Boehringer Ingelheim
Fish and Richardson
Farmers Insurance
Covington

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