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FDA NDA · NDA210997

GLYRX-PF

glycopyrrolate

Sponsor: EXELA PHARMA

APPLICATION
NDA210997
TYPE
NDA
ORIGINAL APPROVAL
2018-07-11
LATEST ACTION
2025-07-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

GLYRX-PF · ReferencePrescription
GLYCOPYRROLATE 1MG/5ML (0.2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
GLYRX-PF · ReferenceDiscontinued
GLYCOPYRROLATE 0.2MG/ML (0.2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
GLYRX-PF · ReferenceDiscontinued
GLYCOPYRROLATE 0.6MG/3ML (0.2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
GLYRX-PF · ReferencePrescription
GLYCOPYRROLATE 0.4MG/2ML (0.2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS

Approval history

2025-07-16Efficacy · Supplement 8 · standard — Letter ↗AP
2018-07-11Efficacy · Original · standard — Label ↗AP
2018-07-11Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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