APPLICATION
NDA016269
TYPE
NDA
ORIGINAL APPROVAL
1967-12-22
LATEST ACTION
2020-03-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
MANNITOL 25%Discontinued
MANNITOL 12.5GM/50ML · INJECTABLE · INJECTION
MANNITOL 15%Discontinued
MANNITOL 15GM/100ML · INJECTABLE · INJECTION
MANNITOL 5%Discontinued
MANNITOL 5GM/100ML · INJECTABLE · INJECTION
MANNITOL 25%Prescription
MANNITOL 12.5GM/50ML · INJECTABLE · INJECTION
MANNITOL 20%Discontinued
MANNITOL 20GM/100ML · INJECTABLE · INJECTION
MANNITOL 10%Discontinued
MANNITOL 10GM/100ML · INJECTABLE · INJECTION
Approval history
2015-10-08Manufacturing (CMC) · Supplement 52 · standardAP
2015-04-08Manufacturing (CMC) · Supplement 51 · standardAP
2002-11-18Manufacturing (CMC) · Supplement 43 · standardAP
2002-09-05Labeling · Supplement 41AP
1997-01-17Manufacturing (CMC) · Supplement 40 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 38 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 39 · standardAP
1994-08-25Labeling · Supplement 37AP
1991-06-04Manufacturing (CMC) · Supplement 36 · standardAP
1988-02-01Manufacturing (CMC) · Supplement 35 · standardAP
1985-11-22Manufacturing (CMC) · Supplement 33 · standardAP
1983-07-05Manufacturing (CMC) · Supplement 32 · standardAP
1982-10-04Manufacturing (CMC) · Supplement 28 · standardAP
1982-06-17Labeling · Supplement 27AP
1982-05-05Labeling · Supplement 31AP
1981-09-01Labeling · Supplement 30AP
1981-02-02Manufacturing (CMC) · Supplement 29 · standardAP
1981-01-13Manufacturing (CMC) · Supplement 26 · standardAP
1980-10-02Labeling · Supplement 24AP
1980-09-25Manufacturing (CMC) · Supplement 25 · standardAP
1980-09-03Manufacturing (CMC) · Supplement 23 · standardAP
1980-07-22Labeling · Supplement 18AP
1980-07-22Manufacturing (CMC) · Supplement 17 · standardAP
1980-06-10Manufacturing (CMC) · Supplement 22 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 21 · standardAP
1980-05-27Manufacturing (CMC) · Supplement 20 · standardAP
1980-01-08Manufacturing (CMC) · Supplement 19 · standardAP
1978-09-07Manufacturing (CMC) · Supplement 14 · standardAP
1978-08-18Manufacturing (CMC) · Supplement 16 · standardAP
1977-12-02Manufacturing (CMC) · Supplement 15 · standardAP
1977-02-04Manufacturing (CMC) · Supplement 13 · standardAP
1976-03-01Manufacturing (CMC) · Supplement 12 · standardAP
1967-12-22Type 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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