APPLICATION
NDA018632
TYPE
NDA
ORIGINAL APPROVAL
1982-06-30
LATEST ACTION
2016-05-26
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
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER · ReferencePrescription
STERILE WATER FOR INJECTION 100% · LIQUID · N/A
Approval history
2014-09-26Manufacturing (CMC) · Supplement 50 · standardAP
2006-07-10Labeling · Supplement 43AP
2005-05-11Labeling · Supplement 40AP
2004-01-23Labeling · Supplement 34AP
2001-08-29Manufacturing (CMC) · Supplement 33 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 32 · standardAP
1999-07-02Labeling · Supplement 31AP
1998-07-28Labeling · Supplement 30AP
1997-07-15Manufacturing (CMC) · Supplement 29 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 28 · standardAP
1995-02-07Labeling · Supplement 27AP
1994-09-30Manufacturing (CMC) · Supplement 25 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 26 · standardAP
1993-12-08Manufacturing (CMC) · Supplement 24 · standardAP
1992-12-11Labeling · Supplement 21AP
1991-03-26Manufacturing (CMC) · Supplement 22 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 19 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 20 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 18 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 17 · standardAP
1988-04-19Labeling · Supplement 16AP
1987-11-16Manufacturing (CMC) · Supplement 12 · standardAP
1987-11-16Labeling · Supplement 13AP
1987-07-25Manufacturing (CMC) · Supplement 14 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 11 · standardAP
1986-09-09Labeling · Supplement 10AP
1986-09-09Manufacturing (CMC) · Supplement 9 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 8 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 5 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 7 · standardAP
1985-01-26Labeling · Supplement 6AP
1984-09-22Manufacturing (CMC) · Supplement 4 · standardAP
1984-03-14Labeling · Supplement 2AP
1984-02-28Manufacturing (CMC) · Supplement 3 · standardAP
1982-06-30Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.