APPLICATION
NDA016366
TYPE
NDA
ORIGINAL APPROVAL
1972-02-24
LATEST ACTION
2017-09-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2016-04-27Manufacturing (CMC) · Supplement 215 · standardAP
2014-09-17Manufacturing (CMC) · Supplement 201 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 212 · standardAP
2007-04-16Labeling · Supplement 174AP
2006-04-10Labeling · Supplement 167AP
2002-11-01Manufacturing (CMC) · Supplement 161 · standardAP
2000-05-03Labeling · Supplement 160AP
2000-05-03Manufacturing (CMC) · Supplement 159 · standardAP
1999-06-25Labeling · Supplement 153AP
1998-12-01Manufacturing (CMC) · Supplement 157 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 156 · standardAP
1997-08-20Manufacturing (CMC) · Supplement 155 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 154 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 152 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 151 · standardAP
1996-03-29Manufacturing (CMC) · Supplement 148 · standardAP
1996-03-29Manufacturing (CMC) · Supplement 149 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 150 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 146 · standardAP
1994-05-24Labeling · Supplement 145AP
1992-01-28Manufacturing (CMC) · Supplement 141 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 140 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 142 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 137 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 138 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 136 · standardAP
1988-10-17Manufacturing (CMC) · Supplement 135 · standardAP
1988-06-07Manufacturing (CMC) · Supplement 134 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 131 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 130 · standardAP
1986-08-06Manufacturing (CMC) · Supplement 96 · standardAP
1986-06-24Manufacturing (CMC) · Supplement 129 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 97 · standardAP
1986-02-22Manufacturing (CMC) · Supplement 127 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 120 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 128 · standardAP
1985-11-29Labeling · Supplement 100AP
1985-11-29Manufacturing (CMC) · Supplement 99 · standardAP
1985-11-07Labeling · Supplement 122AP
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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