APPLICATION
ANDA083051
TYPE
ANDA
ORIGINAL APPROVAL
1975-08-29
LATEST ACTION
1998-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MANNITOL 25%Discontinued
MANNITOL 12.5GM/50ML · INJECTABLE · INJECTION
Approval history
1998-01-14Manufacturing (CMC) · Supplement 15AP
1995-09-19Manufacturing (CMC) · Supplement 17AP
1994-06-17Manufacturing (CMC) · Supplement 16AP
1993-10-29Manufacturing (CMC) · Supplement 14AP
1992-12-17Manufacturing (CMC) · Supplement 12AP
1992-12-07Labeling · Supplement 13AP
1992-12-07Labeling · Supplement 11AP
1987-01-29Manufacturing (CMC) · Supplement 7AP
1985-08-29Manufacturing (CMC) · Supplement 5AP
1975-08-29OriginalAP
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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