NDA 211302

RECORDATI RARE

FDA Drug Application

Application #211302

Documents

• Letter: 2020-08-20
• Label: 2020-08-20
• Review: 2021-05-07

Application Sponsors

NDA 211302

RECORDATI RARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; OPHTHALMIC

3.8 MG/ML

0

CYSTADROPS

CYSTEAMINE OPHTHALMIC SOLUTION

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-08-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

RECORDATI RARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211302
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSTADROPS","activeIngredients":"CYSTEAMINE HYDROCHLORIDE","strength":"EQ 0.37% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/19\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211302s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211302s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211302Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-19
        )

)