FDA NDA · NDA018802

BACTERIOSTATIC WATER

Sponsor: HOSPIRA

APPLICATION

NDA018802

TYPE

NDA

ORIGINAL APPROVAL

1982-10-27

LATEST ACTION

2016-12-22

ROUTE

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, N/A

DOSAGE FORM

LIQUID

MARKETING STATUS

Prescription

Products

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER · ReferencePrescription

STERILE WATER FOR INJECTION 100% · LIQUID · N/A

2016-12-22Manufacturing (CMC) · Supplement 27 · standardAP

2015-06-26Manufacturing (CMC) · Supplement 26 · standardAP

2014-06-12Manufacturing (CMC) · Supplement 25 · standardAP

2000-06-15Labeling · Supplement 13 · standardAP

1999-06-23Manufacturing (CMC) · Supplement 12 · standardAP

1997-11-19Labeling · Supplement 10 · standardAP

1997-09-30Manufacturing (CMC) · Supplement 11 · standardAP

1996-08-29Manufacturing (CMC) · Supplement 9 · standardAP

1988-10-23Manufacturing (CMC) · Supplement 6 · standardAP

1985-03-15Manufacturing (CMC) · Supplement 4 · standardAP

1984-10-22Manufacturing (CMC) · Supplement 5 · standardAP

1984-06-14Manufacturing (CMC) · Supplement 2 · standardAP

1984-01-25Manufacturing (CMC) · Supplement 1 · standardAP

1984-01-17Manufacturing (CMC) · Supplement 3 · standardAP

1982-10-27Type 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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