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FDA ANDA · ANDA065441

CEFEPIME

cefepime hydrochloride

Sponsor: ACS DOBFAR

APPLICATION
ANDA065441
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-20
LATEST ACTION
2022-01-03
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFEPIME HYDROCHLORIDEPrescription
CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFEPIME HYDROCHLORIDEPrescription
CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-01-03Labeling · Supplement 26 · standardAP
2020-05-25Labeling · Supplement 19 · standardAP
2020-05-25Labeling · Supplement 21 · standardAP
2020-05-25Labeling · Supplement 18 · standardAP
2020-05-25Labeling · Supplement 16 · standardAP
2020-05-25Labeling · Supplement 20 · standardAP
2013-03-26Labeling · Supplement 14 · standardAP
2011-09-29Labeling · Supplement 7AP
2008-03-20Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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