APPLICATION
ANDA208790
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-16
LATEST ACTION
2022-08-25
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
2022-08-25Labeling · Supplement 7 · standardAP
2022-08-25Labeling · Supplement 5 · standardAP
2020-08-21Labeling · Supplement 1 · standardAP
2020-08-21Labeling · Supplement 2 · 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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