APPLICATION
ANDA089335
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-23
LATEST ACTION
2019-09-04
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 0.2MG/ML · INJECTABLE · INJECTION
Approval history
2019-09-04Labeling · Supplement 23 · standardAP
2006-09-26Labeling · Supplement 15AP
1997-06-23Manufacturing (CMC) · Supplement 10AP
1996-02-28Manufacturing (CMC) · Supplement 9AP
1991-05-09Manufacturing (CMC) · Supplement 3AP
1991-05-09Manufacturing (CMC) · Supplement 8AP
1991-05-09Manufacturing (CMC) · Supplement 4AP
1991-03-04Manufacturing (CMC) · Supplement 5AP
1990-03-15Labeling · Supplement 7AP
1990-01-25Labeling · Supplement 6AP
1988-09-08Labeling · Supplement 2AP
1986-07-23OriginalAP
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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