APPLICATION
NDA019603
TYPE
NDA
ORIGINAL APPROVAL
1987-01-08
LATEST ACTION
2020-04-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
MANNITOL 15% IN PLASTIC CONTAINERDiscontinued
MANNITOL 15GM/100ML · INJECTABLE · INJECTION
MANNITOL 5% IN PLASTIC CONTAINERDiscontinued
MANNITOL 5GM/100ML · INJECTABLE · INJECTION
MANNITOL 20% IN PLASTIC CONTAINERPrescription
MANNITOL 20GM/100ML · INJECTABLE · INJECTION
MANNITOL 10% IN PLASTIC CONTAINERDiscontinued
MANNITOL 10GM/100ML · INJECTABLE · INJECTION
Approval history
2000-07-10Manufacturing (CMC) · Supplement 18 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 17 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 16 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 15 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 14 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 13 · standardAP
1994-08-25Labeling · Supplement 10AP
1992-01-28Manufacturing (CMC) · Supplement 8 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 7 · standardAP
1990-06-04Manufacturing (CMC) · Supplement 5 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 3 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 4 · standardAP
1990-01-08Labeling · Supplement 2AP
1990-01-08Manufacturing (CMC) · Supplement 1 · standardAP
1987-01-08Type 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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