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TYBLUME

NDA · New Drug Application · Sponsor: EXELTIS USA INC · Approved 2020-03-30

Drug application

FDA Application #

NDA209405

Application type

New Drug Application

Brand name

TYBLUME

Generic name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

EXELTIS USA INC

Manufacturer

Exeltis USA, Inc.

First approval

2020-03-30

Source

Authoritative

Drugs@FDA application overview

Machine

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