ANDA 040400

SPECGX LLC

FDA Drug Application

Application #040400

Documents

• Letter: 2000-07-26

Application Sponsors

ANDA 040400

SPECGX LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;10MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2000-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-08-16
LABELING; Labeling	SUPPL	3	AP	2003-01-22
LABELING; Labeling	SUPPL	6	AP	2003-10-21
LABELING; Labeling	SUPPL	10	AP	2004-12-14
LABELING; Labeling	SUPPL	12	AP	2006-03-27
LABELING; Labeling	SUPPL	15	AP	2010-09-15
LABELING; Labeling	SUPPL	16	AP	2011-06-24
LABELING; Labeling	SUPPL	20	AP	2013-10-25	STANDARD
LABELING; Labeling	SUPPL	23	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2017-03-20	UNKNOWN
REMS; REMS	SUPPL	27	AP	2018-09-18
LABELING; Labeling	SUPPL	28	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	16	Null	7
SUPPL	20	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	15
SUPPL	28	Null	15
SUPPL	30	Null	15
SUPPL	33	Null	7

TE Codes

001

Prescription

AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40400
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)