APPLICATION
NDA019759
TYPE
NDA
ORIGINAL APPROVAL
1988-06-08
LATEST ACTION
2019-05-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2019-05-29Manufacturing (CMC) · Supplement 50AP
2002-11-01Manufacturing (CMC) · Supplement 32 · standardAP
2000-04-06Labeling · Supplement 30AP
2000-04-06Manufacturing (CMC) · Supplement 29 · standardAP
2000-04-06Manufacturing (CMC) · Supplement 31 · standardAP
1999-07-02Labeling · Supplement 25AP
1998-12-01Manufacturing (CMC) · Supplement 28 · standardAP
1997-08-20Manufacturing (CMC) · Supplement 27 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 26 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 22 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 24 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 21 · standardAP
1995-05-31Manufacturing (CMC) · Supplement 23 · standardAP
1995-01-05Manufacturing (CMC) · Supplement 19 · standardAP
1994-09-23Manufacturing (CMC) · Supplement 20 · standardAP
1994-02-25Manufacturing (CMC) · Supplement 18 · standardAP
1993-12-01Manufacturing (CMC) · Supplement 7 · standardAP
1993-12-01Labeling · Supplement 8AP
1993-02-16Labeling · Supplement 10AP
1992-01-28Manufacturing (CMC) · Supplement 12 · standardAP
1991-12-30Manufacturing (CMC) · Supplement 15 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 11 · standardAP
1990-11-02Manufacturing (CMC) · Supplement 9 · standardAP
1990-03-09Manufacturing (CMC) · Supplement 6 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 5 · standardAP
1989-09-20Labeling · Supplement 2AP
1989-07-18Manufacturing (CMC) · Supplement 3 · standardAP
1988-12-06Labeling · Supplement 1AP
1988-06-08Type 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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