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FDA ANDA · ANDA087409

MANNITOL 25%

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APPLICATION
ANDA087409
TYPE
ANDA
ORIGINAL APPROVAL
1982-01-21
LATEST ACTION
1997-10-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MANNITOL 25%Discontinued
MANNITOL 12.5GM/50ML · INJECTABLE · INJECTION

Approval history

1997-10-27Manufacturing (CMC) · Supplement 21AP
1997-02-28Manufacturing (CMC) · Supplement 20AP
1991-04-22Manufacturing (CMC) · Supplement 14AP
1991-04-22Manufacturing (CMC) · Supplement 17AP
1991-04-22Manufacturing (CMC) · Supplement 13AP
1991-04-22Manufacturing (CMC) · Supplement 18AP
1989-05-09Manufacturing (CMC) · Supplement 16AP
1989-02-13Labeling · Supplement 15AP
1985-05-09Manufacturing (CMC) · Supplement 7AP
1985-05-09Manufacturing (CMC) · Supplement 6AP
1982-10-22Manufacturing (CMC) · Supplement 1AP
1982-09-17Manufacturing (CMC) · Supplement 2AP
1982-01-21OriginalAP
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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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