APPLICATION
ANDA088400
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-16
LATEST ACTION
2015-11-23
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, N/A
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER FOR INJECTION IN PLASTIC CONTAINERPrescription
STERILE WATER FOR INJECTION 100% · LIQUID · N/A
Approval history
2015-11-23Labeling · Supplement 30 · standardAP
2007-08-08Labeling · Supplement 23AP
2007-05-21Manufacturing (CMC) · Supplement 25AP
2002-07-12Manufacturing (CMC) · Supplement 21AP
2001-09-25Labeling · Supplement 20AP
1992-11-02Labeling · Supplement 19AP
1991-05-29Manufacturing (CMC) · Supplement 17AP
1991-02-21Labeling · Supplement 18AP
1988-10-24Manufacturing (CMC) · Supplement 9AP
1988-10-24Manufacturing (CMC) · Supplement 11AP
1988-10-24Manufacturing (CMC) · Supplement 12AP
1988-10-24Manufacturing (CMC) · Supplement 10AP
1987-03-19Manufacturing (CMC) · Supplement 8AP
1986-06-09Manufacturing (CMC) · Supplement 7AP
1985-01-07Manufacturing (CMC) · Supplement 2AP
1984-12-28Manufacturing (CMC) · Supplement 1AP
1984-01-16OriginalAP
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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