APPLICATION
ANDA089454
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-07
LATEST ACTION
2007-06-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PROTAMINE SULFATEPrescription
PROTAMINE SULFATE 250MG/25ML (10MG/ML) · SOLUTION · INTRAVENOUS
PROTAMINE SULFATEPrescription
PROTAMINE SULFATE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2007-06-11Labeling · Supplement 15AP
2007-03-29Labeling · Supplement 14AP
2002-12-05Manufacturing (CMC) · Supplement 12AP
2002-03-01Manufacturing (CMC) · Supplement 11AP
1992-10-27Labeling · Supplement 7AP
1991-02-22Manufacturing (CMC) · Supplement 5AP
1990-05-23Labeling · Supplement 8AP
1987-08-25Manufacturing (CMC) · Supplement 2AP
1987-04-07OriginalAP
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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