FDA NDA · NDA019869

STERILE WATER

water

Sponsor: OTSUKA ICU MEDCL

APPLICATION

NDA019869

TYPE

NDA

ORIGINAL APPROVAL

1989-12-26

LATEST ACTION

2003-05-20

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

2003-05-20Labeling · Supplement 12AP

2002-03-20Manufacturing (CMC) · Supplement 10 · standardAP

2001-06-26Manufacturing (CMC) · Supplement 9 · standardAP

1999-11-04Labeling · Supplement 8AP

1996-08-27Manufacturing (CMC) · Supplement 6 · standardAP

1995-08-14Manufacturing (CMC) · Supplement 7 · standardAP

1992-01-28Manufacturing (CMC) · Supplement 4 · standardAP

1991-09-10Manufacturing (CMC) · Supplement 3 · standardAP

1990-07-31Manufacturing (CMC) · Supplement 1 · standardAP

1989-12-26Type 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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