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MIUDELLA

NDA · New Drug Application · Sponsor: SEBELA WOMENS HLTH · Approved 2025-02-24

Drug application

FDA Application #

NDA218201

Application type

New Drug Application

Brand name

MIUDELLA

Generic name

COPPER

Active ingredients

COPPER

Dosage form

SYSTEM

Route

INTRAUTERINE

Marketing status

Prescription

Sponsor

SEBELA WOMENS HLTH

Manufacturer

Sebela Women's Health Inc.

First approval

2025-02-24

Source

Authoritative

Drugs@FDA application overview

Machine

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