APPLICATION
NDA018243
TYPE
NDA
ORIGINAL APPROVAL
1980-04-29
LATEST ACTION
2014-05-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OXYTOCIN · ReferencePrescription
OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) · INJECTABLE · INJECTION
OXYTOCIN · ReferencePrescription
OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) · INJECTABLE · INJECTION
Approval history
2014-05-09Manufacturing (CMC) · Supplement 16 · standardAP
2007-01-10Manufacturing (CMC) · Supplement 13AP
1995-03-22Labeling · Supplement 12 · standardAP
1993-12-23Manufacturing (CMC) · Supplement 11 · standardAP
1993-09-16Manufacturing (CMC) · Supplement 10 · standardAP
1990-01-22Manufacturing (CMC) · Supplement 9 · standardAP
1988-08-02Labeling · Supplement 8AP
1987-09-24Manufacturing (CMC) · Supplement 6 · standardAP
1987-07-14Labeling · Supplement 7AP
1986-07-28Labeling · Supplement 5AP
1984-06-14Labeling · Supplement 2AP
1984-01-31Manufacturing (CMC) · Supplement 4 · standardAP
1983-07-01Manufacturing (CMC) · Supplement 3 · standardAP
1980-08-14Manufacturing (CMC) · Supplement 1 · standardAP
1980-04-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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