ANDA 206129

SUN PHARM

FDA Drug Application

Application #206129

Documents

• Letter: 2015-08-19
• Label: 2015-08-26

Application Sponsors

ANDA 206129

SUN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	12.5MG	0	TETRABENAZINE	TETRABENAZINE
002	TABLET;ORAL	25MG	0	TETRABENAZINE	TETRABENAZINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206129
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/17\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206129Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206129Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206129Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/04\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-04
        )

)