APPLICATION
ANDA080677
TYPE
ANDA
ORIGINAL APPROVAL
1972-08-11
LATEST ACTION
1999-08-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MANNITOL 25%Prescription
MANNITOL 12.5GM/50ML · INJECTABLE · INJECTION
Approval history
1999-08-13Manufacturing (CMC) · Supplement 30AP
1995-07-14Manufacturing (CMC) · Supplement 35AP
1994-12-06Manufacturing (CMC) · Supplement 31AP
1993-04-08Labeling · Supplement 34AP
1992-05-01Labeling · Supplement 33AP
1991-06-19Labeling · Supplement 32AP
1989-01-11Manufacturing (CMC) · Supplement 28AP
1989-01-11Manufacturing (CMC) · Supplement 29AP
1985-12-12Manufacturing (CMC) · Supplement 26AP
1985-10-18Manufacturing (CMC) · Supplement 25AP
1985-01-10Manufacturing (CMC) · Supplement 23AP
1983-09-20Manufacturing (CMC) · Supplement 22AP
1982-11-08Manufacturing (CMC) · Supplement 19AP
1982-11-01Manufacturing (CMC) · Supplement 20AP
1972-08-11OriginalAP
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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