ANDA 075983

SPECGX LLC

FDA Drug Application

Application #075983

Documents

• Letter: 2002-06-25
• Label: 2002-06-25

Application Sponsors

ANDA 075983

SPECGX LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-06-25
LABELING; Labeling	SUPPL	4	AP	2002-11-22
LABELING; Labeling	SUPPL	8	AP	2004-08-11
LABELING; Labeling	SUPPL	11	AP	2005-11-17
REMS; REMS	SUPPL	12	AP	2018-09-18

Submissions Property Types

SUPPL

12

Null

7

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75983
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/25\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/75983lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-06-25
        )

)