ANDA 076570

SUN PHARM INDUSTRIES

FDA Drug Application

Application #076570

Application Sponsors

ANDA 076570

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG

0

TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-08-28
LABELING; Labeling	SUPPL	9	AP	2008-06-18
LABELING; Labeling	SUPPL	11	AP	2010-10-29
LABELING; Labeling	SUPPL	18	AP	2020-04-22	STANDARD

Submissions Property Types

SUPPL	11	Null	7
SUPPL	18	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76570
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMETHOBENZAMIDE HYDROCHLORIDE","activeIngredients":"TRIMETHOBENZAMIDE HYDROCHLORIDE","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMETHOBENZAMIDE HYDROCHLORIDE","submission":"TRIMETHOBENZAMIDE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)