APPLICATION
ANDA089474
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-05
LATEST ACTION
2000-06-29
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
PROTAMINE SULFATEDiscontinued
PROTAMINE SULFATE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2000-06-29Manufacturing (CMC) · Supplement 13AP
1999-03-29Manufacturing (CMC) · Supplement 12AP
1998-11-05Manufacturing (CMC) · Supplement 11AP
1996-01-30Labeling · Supplement 10AP
1994-12-28Manufacturing (CMC) · Supplement 9AP
1992-08-14Labeling · Supplement 6AP
1990-12-26Labeling · Supplement 8AP
1989-05-17Labeling · Supplement 5AP
1988-10-28Labeling · Supplement 4AP
1988-03-08Manufacturing (CMC) · Supplement 2AP
1987-11-06Manufacturing (CMC) · Supplement 3AP
1986-11-05OriginalAP
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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