APPLICATION
NDA018248
TYPE
NDA
ORIGINAL APPROVAL
1980-07-09
LATEST ACTION
2022-09-20
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OXYTOCIN · ReferencePrescription
OXYTOCIN 100USP UNITS/10ML (10USP UNITS/ML) · INJECTABLE · INJECTION
OXYTOCIN · ReferencePrescription
OXYTOCIN 300USP UNITS/30ML (10USP UNITS/ML) · INJECTABLE · INJECTION
OXYTOCIN · ReferencePrescription
OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) · INJECTABLE · INJECTION
Approval history
2014-09-10Manufacturing (CMC) · Supplement 42 · standardAP
2000-10-11Manufacturing (CMC) · Supplement 28 · standardAP
1999-07-02Manufacturing (CMC) · Supplement 25 · standardAP
1999-01-20Manufacturing (CMC) · Supplement 19 · standardAP
1997-10-17Manufacturing (CMC) · Supplement 24 · standardAP
1995-01-13Manufacturing (CMC) · Supplement 22 · standardAP
1994-12-16Manufacturing (CMC) · Supplement 20 · standardAP
1994-11-23Labeling · Supplement 23 · standardAP
1988-02-16Manufacturing (CMC) · Supplement 18 · standardAP
1987-02-24Labeling · Supplement 17AP
1986-10-14Labeling · Supplement 15AP
1986-09-19Manufacturing (CMC) · Supplement 16 · standardAP
1985-03-14Manufacturing (CMC) · Supplement 14 · standardAP
1984-07-23Manufacturing (CMC) · Supplement 13 · standardAP
1983-11-08Manufacturing (CMC) · Supplement 12 · standardAP
1983-08-10Labeling · Supplement 11AP
1983-04-14Labeling · Supplement 8AP
1982-11-12Manufacturing (CMC) · Supplement 9 · standardAP
1982-03-10Manufacturing (CMC) · Supplement 7 · standardAP
1980-07-09Type 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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