APPLICATION
ANDA202675
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-15
LATEST ACTION
2023-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 1MG · TABLET · ORAL
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 2MG · TABLET · ORAL
Approval history
2023-04-18Labeling · Supplement 4 · standardAP
2018-10-30UNKNOWN · OriginalAP
2013-04-15UNKNOWN · OriginalAP
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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