ANDA 040779

AMNEAL PHARMS NY

FDA Drug Application

Application #040779

Application Sponsors

ANDA 040779

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG;30MG

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2008-05-29
LABELING; Labeling	SUPPL	5	AP	2016-03-23
LABELING; Labeling	SUPPL	8	AP	2011-06-23
LABELING; Labeling	SUPPL	11	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-08-29	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-09-21	STANDARD
REMS; REMS	SUPPL	19	AP	2018-09-18
LABELING; Labeling	SUPPL	21	AP	2019-10-08	STANDARD
LABELING; Labeling	SUPPL	24	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	7
SUPPL	21	Null	15
SUPPL	24	Null	7

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40779
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)