ANDA 205342

CINTEX SVCS

FDA Drug Application

Application #205342

Documents

• Letter: 2016-04-15
• Label: 2016-04-20

Application Sponsors

ANDA 205342

CINTEX SVCS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

FLURANDRENOLIDE

FLURANDRENOLIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

CINTEX SVCS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205342
            [companyName] => CINTEX SVCS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURANDRENOLIDE","activeIngredients":"FLURANDRENOLIDE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/13\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205342Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205342Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205342Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-04-13
        )

)