ANDA 205880

NAVINTA LLC

FDA Drug Application

Application #205880

Documents

• Letter: 2016-10-12
• Label: 2016-10-27

Application Sponsors

ANDA 205880

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

10%;10% (5GM/50ML;5GM/50ML)

0

SODIUM PHENYLACETATE AND SODIUM BENZOATE

SODIUM BENZOATE; SODIUM PHENYLACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-04

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205880
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLACETATE AND SODIUM BENZOATE","activeIngredients":"SODIUM BENZOATE; SODIUM PHENYLACETATE","strength":"10%;10% (5GM\/50ML;5GM\/50ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/04\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205880Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/04\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205880Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205880Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-08-04
        )

)