ANDA 040163

SPECGX LLC

FDA Drug Application

Application #040163

Application Sponsors

ANDA 040163

SPECGX LLC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

MEPERIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-05-12
LABELING; Labeling	SUPPL	2	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-11	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40163
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)