← FDA DRUG APPROVALS

FDA NDA · NDA210660

ELCYS

cysteine hydrochloride

Sponsor: EXELA PHARMA

APPLICATION
NDA210660
TYPE
NDA
ORIGINAL APPROVAL
2019-04-16
LATEST ACTION
2023-12-04
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

ELCYS · ReferencePrescription
CYSTEINE HYDROCHLORIDE 500MG/10ML (50MG/ML) · SOLUTION · INTRAVENOUS
ELCYS · ReferenceDiscontinued
CYSTEINE HYDROCHLORIDE 2500MG/50ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-12-04Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2019-04-16Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗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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