APPLICATION
ANDA089393
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-15
LATEST ACTION
1998-05-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
GLYCOPYRROLATEDiscontinued
GLYCOPYRROLATE 0.2MG/ML · INJECTABLE · INJECTION
Approval history
1998-05-05Manufacturing (CMC) · Supplement 6AP
1996-10-03Manufacturing (CMC) · Supplement 4AP
1991-05-20Labeling · Supplement 1AP
1988-06-15OriginalAP
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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