APPLICATION
NDA014764
TYPE
NDA
LATEST ACTION
1980-04-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ROBINULDiscontinued
GLYCOPYRROLATE 0.2MG/ML · INJECTABLE · INJECTION
Approval history
1980-04-02Manufacturing (CMC) · Supplement 20 · standardAP
1980-04-02Manufacturing (CMC) · Supplement 7 · standardAP
1980-03-28Manufacturing (CMC) · Supplement 22 · standardAP
1980-03-28Manufacturing (CMC) · Supplement 23 · standardAP
1978-08-07Labeling · Supplement 19AP
1978-07-17Labeling · Supplement 18AP
1978-05-31Manufacturing (CMC) · Supplement 16 · standardAP
1977-12-12Manufacturing (CMC) · Supplement 15 · standardAP
1977-09-07Manufacturing (CMC) · Supplement 14 · standardAP
1976-03-19Manufacturing (CMC) · Supplement 10 · standardAP
1976-02-09Manufacturing (CMC) · Supplement 9 · standardAP
1975-12-17Labeling · Supplement 8AP
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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