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FDA ANDA · ANDA090577

IMIPENEM AND CILASTATIN

imipenem and cilastatin sodium

Sponsor: ACS DOBFAR

APPLICATION
ANDA090577
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-21
LATEST ACTION
2024-02-05
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

IMIPENEM AND CILASTATINPrescription
CILASTATIN SODIUM EQ 500MG BASE/VIAL, IMIPENEM 500MG/VIAL · POWDER · INTRAVENOUS
IMIPENEM AND CILASTATINPrescription
CILASTATIN SODIUM EQ 250MG BASE/VIAL, IMIPENEM 250MG/VIAL · POWDER · INTRAVENOUS

Approval history

2024-02-05Labeling · Supplement 16 · standardAP
2019-07-09Labeling · Supplement 12 · standardAP
2019-07-09Labeling · Supplement 10 · standardAP
2015-05-29Labeling · Supplement 6 · standardAP
2015-05-29Labeling · Supplement 3 · standardAP
2015-04-15Labeling · Supplement 1AP
2011-12-21OriginalAP
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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