APPLICATION
ANDA090963
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-21
LATEST ACTION
2019-08-31
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 0.2MG/ML · INJECTABLE · INJECTION
Approval history
2019-08-31Labeling · Supplement 12 · standardAP
2011-09-21OriginalAP
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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