← FDA DRUG APPROVALS

FDA NDA · NDA211302

CYSTADROPS

cysteamine hydrochloride

Sponsor: RECORDATI RARE

APPLICATION
NDA211302
TYPE
NDA
ORIGINAL APPROVAL
2020-08-19
LATEST ACTION
2020-08-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

CYSTADROPS · ReferencePrescription
CYSTEAMINE HYDROCHLORIDE EQ 0.37% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2020-08-19Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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