APPLICATION
ANDA207647
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-19
LATEST ACTION
2022-02-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ERTAPENEM SODIUMPrescription
ERTAPENEM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
Approval history
2022-02-08Labeling · Supplement 10 · standardAP
2020-06-09Labeling · Supplement 4 · standardAP
2019-03-19UNKNOWN · 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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