APPLICATION
NDA018261
TYPE
NDA
ORIGINAL APPROVAL
1980-11-19
LATEST ACTION
2021-05-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PITOCIN · ReferencePrescription
OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) · INJECTABLE · INJECTION
PITOCIN · ReferencePrescription
OXYTOCIN 500USP UNITS/50ML (10USP UNITS/ML) · INJECTABLE · INJECTION
PITOCIN · ReferencePrescription
OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) · INJECTABLE · INJECTION
Approval history
2016-08-15Manufacturing (CMC) · Supplement 33AP
2014-06-18Manufacturing (CMC) · Supplement 32 · standardAP
2001-09-24Manufacturing (CMC) · Supplement 22 · standardAP
2001-03-08Labeling · Supplement 20 · standardAP
2001-03-08Manufacturing (CMC) · Supplement 19 · standardAP
2001-03-08Manufacturing (CMC) · Supplement 18 · standardAP
2000-10-25Manufacturing (CMC) · Supplement 17 · standardAP
2000-03-23Manufacturing (CMC) · Supplement 16 · standardAP
2000-03-01Manufacturing (CMC) · Supplement 15 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 14 · standardAP
1999-02-22Labeling · Supplement 13 · standardAP
1997-07-10Manufacturing (CMC) · Supplement 12 · standardAP
1996-02-22Labeling · Supplement 9 · standardAP
1994-08-23Labeling · Supplement 7 · standardAP
1994-08-09Labeling · Supplement 6AP
1994-05-27Manufacturing (CMC) · Supplement 8 · standardAP
1990-07-03Labeling · Supplement 5AP
1988-02-16Labeling · Supplement 4AP
1987-01-29Manufacturing (CMC) · Supplement 3 · standardAP
1986-09-19Labeling · Supplement 2AP
1984-01-27Manufacturing (CMC) · Supplement 1 · standardAP
1980-11-19Type 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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