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FDA ANDA · ANDA203183

CISATRACURIUM

cisatracurium besylate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA203183
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-26
LATEST ACTION
2025-06-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CISATRACURIUM BESYLATEPrescription
CISATRACURIUM BESYLATE EQ 2MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-06-17Labeling · Supplement 12 · standardAP
2016-06-23Labeling · Supplement 1 · standardAP
2015-02-26UNKNOWN · OriginalAP
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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