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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075768

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NDA 075768 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Unichem, Sandoz, Ivax Sub Teva Pharms, Apothecon, Mylan, Watson Labs Teva, Actavis Elizabeth, and Teva, and is included in nine NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

Summary for NDA: 075768

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075768

Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 075768

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate; hydrochlorothiazide
TABLET;ORAL 075768 ANDA Mylan Pharmaceuticals Inc. 0378-0501 0378-0501-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate; hydrochlorothiazide
TABLET;ORAL 075768 ANDA Mylan Pharmaceuticals Inc. 0378-0501 0378-0501-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-10)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 500+ biopharmaceutical companies globally:

Fish and Richardson
Covington
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US Department of Justice
Accenture
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