ANDA 076899

AMNEAL PHARMS NY

FDA Drug Application

Application #076899

Application Sponsors

ANDA 076899

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	400MG;80MG	0	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM
002	TABLET;ORAL	800MG;160MG	0	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

	ORIG	1	AP	2005-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2008-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2007-09-16
LABELING; Labeling	SUPPL	5	AP	2007-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2011-03-17
LABELING; Labeling	SUPPL	11	AP	2012-03-22
LABELING; Labeling	SUPPL	12	AP	2013-02-20	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-12-21	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-09-16	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-09-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	9	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	26	Null	15
SUPPL	29	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76899
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"400MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"800MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"400MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"800MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)