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FDA NDA · NDA200740

CYSTARAN

cysteamine hydrochloride

Sponsor: LEADIANT BIOSCI INC

APPLICATION
NDA200740
TYPE
NDA
ORIGINAL APPROVAL
2012-10-02
LATEST ACTION
2022-02-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

CYSTARAN · ReferencePrescription
CYSTEAMINE HYDROCHLORIDE EQ 0.44% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-02-25Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2020-04-24Labeling · Supplement 1 · standard — Label ↗AP
2012-10-02Type 3 - New Dosage Form · Original · priority — Review ↗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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