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FDA NDA · NDA215019

DARTISLA ODT

Sponsor: EDENBRIDGE PHARMS

APPLICATION
NDA215019
TYPE
NDA
ORIGINAL APPROVAL
2021-12-16
LATEST ACTION
2023-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

DARTISLA ODT · ReferenceDiscontinued
GLYCOPYRROLATE 1.7MG · TABLET, ORALLY DISINTEGRATING · ORAL
DARTISLA ODTDiscontinued
GLYCOPYRROLATE 0.85MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-10-11Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2021-12-16Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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