APPLICATION
ANDA207310
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-19
LATEST ACTION
2022-08-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2022-08-04Manufacturing (CMC) · Supplement 19 · unknownAP
2020-11-19Manufacturing (CMC) · Supplement 12 · unknownAP
2020-07-24Labeling · Supplement 10 · standardAP
2019-10-09Manufacturing (CMC) · Supplement 5 · standardAP
2017-09-19UNKNOWN · 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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