APPLICATION
NDA018245
TYPE
NDA
ORIGINAL APPROVAL
1980-04-17
LATEST ACTION
1997-05-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SYNTOCINONDiscontinued
OXYTOCIN 10USP UNITS/ML · INJECTABLE · INJECTION
Approval history
1997-05-13Manufacturing (CMC) · Supplement 21 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 20 · standardAP
1997-04-29Labeling · Supplement 22 · standardAP
1994-11-14Labeling · Supplement 19 · standardAP
1993-01-21Labeling · Supplement 18AP
1992-06-08Manufacturing (CMC) · Supplement 17 · standardAP
1989-10-20Manufacturing (CMC) · Supplement 16 · standardAP
1986-09-24Manufacturing (CMC) · Supplement 10 · standardAP
1986-02-04Manufacturing (CMC) · Supplement 8 · standardAP
1984-08-16Manufacturing (CMC) · Supplement 7 · standardAP
1984-08-06Labeling · Supplement 6AP
1984-06-07Labeling · Supplement 9 · standardAP
1983-12-07Manufacturing (CMC) · Supplement 4 · standardAP
1981-01-28Manufacturing (CMC) · Supplement 3 · standardAP
1980-07-18Manufacturing (CMC) · Supplement 2 · standardAP
1980-06-09Manufacturing (CMC) · Supplement 1 · standardAP
1980-04-17Type 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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