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FDA NDA · NDA210303

ZEMDRI (PLAZOMICIN)

plazomicin

Sponsor: CIPLA USA

APPLICATION
NDA210303
TYPE
NDA
ORIGINAL APPROVAL
2018-06-25
LATEST ACTION
2023-02-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ZEMDRI · ReferenceDiscontinued
PLAZOMICIN SULFATE EQ 500MG BASE/10ML (EQ 50MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2020-07-15Labeling · Supplement 5 · standard — Letter ↗AP
2018-06-25Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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