General MedicationsORALGeneric
DARTISLA ODT
GLYCOPYRROLATE
Standard Dose
1.7MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview DARTISLA ODT is listed in Drugs@FDA under application 215019 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYCOPYRROLATE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG Sponsor EDENBRIDGE PHARMS Submission history Latest submission status date: 2023-10-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview DARTISLA ODT is listed in Drugs@FDA under application 215019 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYCOPYRROLATE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG Sponsor EDENBRIDGE PHARMS Submission history Latest submission status date: 2023-10-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.