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KYLEENA

NDA · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2016-09-16

Drug application

FDA Application #

NDA208224

Application type

New Drug Application

Brand name

KYLEENA

Generic name

LEVONORGESTREL

Active ingredients

LEVONORGESTREL

Dosage form

SYSTEM

Route

INTRAUTERINE

Marketing status

Prescription

Sponsor

BAYER HLTHCARE

Manufacturer

Bayer HealthCare Pharmaceuticals Inc.

First approval

2016-09-16

Source

Authoritative

Drugs@FDA application overview

Machine

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