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FDA ANDA · ANDA219267

GLYCOPYRROLATE ORAL SOLUTION

glycopyrrolate

Sponsor: AJENAT PHARMS

APPLICATION
ANDA219267
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-27
LATEST ACTION
2025-10-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 1MG/5ML · SOLUTION · ORAL

Approval history

2025-10-27UNKNOWN · Original · standardAP
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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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