APPLICATION
ANDA203704
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-01
LATEST ACTION
2022-01-28
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFEPIME HYDROCHLORIDEPrescription
CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFEPIME HYDROCHLORIDEPrescription
CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFEPIME HYDROCHLORIDEPrescription
CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2022-01-28Labeling · Supplement 14 · standardAP
2020-02-11Labeling · Supplement 7 · standardAP
2017-08-15Labeling · Supplement 4 · standardAP
2017-08-15Labeling · Supplement 2 · standardAP
2016-02-01UNKNOWN · 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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