ANDA 040352

SPECGX LLC

FDA Drug Application

Application #040352

Documents

• Letter: 2000-06-13
• Label: 2004-06-09
• Review: 2003-07-31

Application Sponsors

ANDA 040352

SPECGX LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	50MG	0	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-06-13
LABELING; Labeling	SUPPL	4	AP	2005-11-03
REMS; REMS	SUPPL	5	AP	2018-09-18

Submissions Property Types

SUPPL

5

Null

7

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40352
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/13\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/40352_Meperidine%20Hydrochloride_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-06-13
        )

)