ANDA 076100

SUN PHARM INDUSTRIES

FDA Drug Application

Application #076100

Documents

• Letter: 2002-06-20
• Label: 2002-06-20

Application Sponsors

ANDA 076100

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-06-20
LABELING; Labeling	SUPPL	2	AP	2003-04-25
LABELING; Labeling	SUPPL	16	AP	2006-11-29
REMS; REMS	SUPPL	23	AP	2018-09-18

Submissions Property Types

SUPPL

23

Null

15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76100
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/20\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/76100lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-06-20
        )

)