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FDA NDA · NDA019185

OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

Sponsor: ABBOTT

APPLICATION
NDA019185
TYPE
NDA
ORIGINAL APPROVAL
1985-03-29
LATEST ACTION
1986-11-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OXYTOCIN 10 USP UNITS IN DEXTROSE 5% · ReferenceDiscontinued
OXYTOCIN 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
OXYTOCIN 5 USP UNITS IN DEXTROSE 5% · ReferenceDiscontinued
OXYTOCIN 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
OXYTOCIN 10 USP UNITS IN DEXTROSE 5% · ReferenceDiscontinued
OXYTOCIN 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
OXYTOCIN 20 USP UNITS IN DEXTROSE 5% · ReferenceDiscontinued
OXYTOCIN 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1986-11-13Labeling · Supplement 4AP
1985-07-01Labeling · Supplement 1AP
1985-03-29Type 3 - New Dosage Form · Original · standardAP
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