APPLICATION
NDA006460
TYPE
NDA
ORIGINAL APPROVAL
1969-08-13
LATEST ACTION
1998-04-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
PROTAMINE SULFATE · ReferenceDiscontinued
PROTAMINE SULFATE 250MG/25ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
PROTAMINE SULFATE · ReferenceDiscontinued
PROTAMINE SULFATE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
Approval history
1998-04-22Manufacturing (CMC) · Supplement 31 · standardAP
1997-04-08Manufacturing (CMC) · Supplement 30 · standardAP
1996-12-03Manufacturing (CMC) · Supplement 28 · standardAP
1996-04-19Manufacturing (CMC) · Supplement 29 · standardAP
1994-12-06Labeling · Supplement 27 · standardAP
1993-08-18Labeling · Supplement 26 · standardAP
1991-01-08Labeling · Supplement 24 · standardAP
1990-03-05Labeling · Supplement 23 · standardAP
1989-06-13Labeling · Supplement 22 · standardAP
1988-02-18Manufacturing (CMC) · Supplement 20 · standardAP
1988-01-07Labeling · Supplement 21 · standardAP
1986-05-27Labeling · Supplement 18 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 16 · standardAP
1985-10-24Labeling · Supplement 17 · standardAP
1985-06-17Labeling · Supplement 13 · standardAP
1983-05-25Manufacturing (CMC) · Supplement 15 · standardAP
1982-04-21Labeling · Supplement 14 · standardAP
1982-01-21Labeling · Supplement 12 · standardAP
1981-06-16Manufacturing (CMC) · Supplement 11 · standardAP
1979-10-27Labeling · Supplement 9 · standardAP
1979-09-07Manufacturing (CMC) · Supplement 10 · standardAP
1976-07-21Labeling · Supplement 8 · standardAP
1969-08-13Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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