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BEYAZ

NDA · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2010-09-24

Drug application

FDA Application #

NDA022532

Application type

New Drug Application

Brand name

BEYAZ

Generic name

DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM

Active ingredients

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

BAYER HLTHCARE

Manufacturer

Sandoz Inc

First approval

2010-09-24

Source

Authoritative

Drugs@FDA application overview

Machine

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