← FDA Drug Approvals (Drugs@FDA)

DARTISLA ODT

NDA · New Drug Application · Sponsor: EDENBRIDGE PHARMS · Approved 2021-12-16

Drug application

FDA Application #

NDA215019

Application type

New Drug Application

Brand name

DARTISLA ODT

Generic name

Glycopyrrolate

Active ingredients

GLYCOPYRROLATE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Marketing status

Discontinued

Sponsor

EDENBRIDGE PHARMS

First approval

2021-12-16

Source

Authoritative

Drugs@FDA application overview

Machine

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