APPLICATION
NDA017989
TYPE
NDA
ORIGINAL APPROVAL
1979-01-09
LATEST ACTION
2015-06-19
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEMABATE · ReferencePrescription
CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML · INJECTABLE · INJECTION
Approval history
2015-06-19Manufacturing (CMC) · Supplement 23 · standardAP
2014-06-09Manufacturing (CMC) · Supplement 22 · standardAP
2002-10-15Manufacturing (CMC) · Supplement 14 · standardAP
2000-04-03Manufacturing (CMC) · Supplement 13 · standardAP
1998-05-11Labeling · Supplement 12 · standardAP
1995-08-29Labeling · Supplement 10 · standardAP
1995-08-29Labeling · Supplement 11 · standardAP
1992-05-08Manufacturing (CMC) · Supplement 9 · standardAP
1990-09-03Manufacturing (CMC) · Supplement 8 · standardAP
1988-09-21Labeling · Supplement 7AP
1986-09-08Labeling · Supplement 6AP
1985-05-21Labeling · Supplement 5AP
1983-08-30Labeling · Supplement 4AP
1981-12-29Labeling · Supplement 3AP
1981-03-10Labeling · Supplement 1AP
1980-03-20Labeling · Supplement 2AP
1979-01-09Type 1 - New Molecular Entity · 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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