APPLICATION
NDA019633
TYPE
NDA
ORIGINAL APPROVAL
1988-02-29
LATEST ACTION
2014-08-29
ROUTE
INTRAVENOUS, N/A
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER · ReferencePrescription
STERILE WATER FOR INJECTION 100% · LIQUID · N/A
Approval history
2014-08-29Manufacturing (CMC) · Supplement 31 · standardAP
2003-05-05Labeling · Supplement 19AP
2002-07-01Manufacturing (CMC) · Supplement 17 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 15 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 14 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 13 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 12 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 10 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 8 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 7 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 6 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-28Labeling · Supplement 1AP
1988-02-29Type 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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