APPLICATION
ANDA209133
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-25
LATEST ACTION
2024-06-13
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
2024-06-13Labeling · Supplement 15 · standardAP
2023-01-27Labeling · Supplement 8 · standardAP
2022-01-27Labeling · Supplement 5 · standardAP
2020-06-09Labeling · Supplement 3 · standardAP
2019-08-30Labeling · Supplement 1 · standardAP
2018-06-25UNKNOWN · 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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