NDA 200740

LEADIANT BIOSCI INC

FDA Drug Application

Application #200740

Documents

• Letter: 2012-10-04
• Label: 2012-10-04
• Review: 2013-08-26
• Summary Review: 2013-08-26
• Label: 2020-04-27
• Letter: 2020-04-28
• Letter: 2022-02-28
• Label: 2022-03-02

Application Sponsors

NDA 200740

LEADIANT BIOSCI INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.44% BASE

1

CYSTARAN

CYSTEAMINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2012-10-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2022-02-25	N/A

Submissions Property Types

ORIG

1

Null

7

CDER Filings

LEADIANT BIOSCI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200740
            [companyName] => LEADIANT BIOSCI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSTARAN","activeIngredients":"CYSTEAMINE HYDROCHLORIDE","strength":"EQ 0.44% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200740s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200740s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/02\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200740s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200740Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/200740_cystaran_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/200740Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/200740s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/200740Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-24
        )

)