APPLICATION
ANDA202679
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-07
LATEST ACTION
2021-06-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM BICARBONATEPrescription
SODIUM BICARBONATE 5MEQ/10ML (0.5MEQ/ML) · SOLUTION · INTRAVENOUS
Approval history
2021-06-14Manufacturing (CMC) · Supplement 10 · unknownAP
2017-08-29Labeling · Supplement 2 · standardAP
2017-03-07UNKNOWN · OriginalAP
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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