APPLICATION
NDA018090
TYPE
NDA
ORIGINAL APPROVAL
1979-04-04
LATEST ACTION
2017-09-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2017-04-16Labeling · Supplement 86 · standardAP
2014-09-17Manufacturing (CMC) · Supplement 105 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 114 · standardAP
2007-04-16Labeling · Supplement 87AP
2002-11-01Manufacturing (CMC) · Supplement 81 · standardAP
2001-06-25Manufacturing (CMC) · Supplement 80 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 78 · standardAP
1998-09-21Manufacturing (CMC) · Supplement 77 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 76 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 72 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 71 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 74 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 73 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 70 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 69 · standardAP
1993-10-25Labeling · Supplement 62AP
1993-10-25Manufacturing (CMC) · Supplement 61 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 65 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 64 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 66 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 59 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 60 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 35 · standardAP
1988-02-16Labeling · Supplement 58AP
1988-02-16Manufacturing (CMC) · Supplement 57 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 54 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 53 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 52 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 36 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 49 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 38 · standardAP
1985-11-29Labeling · Supplement 39AP
1985-10-29Manufacturing (CMC) · Supplement 37 · standardAP
1985-10-26Labeling · Supplement 47AP
1985-10-26Manufacturing (CMC) · Supplement 45 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 41 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 51 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 46 · 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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