NDA 018374

SUN PHARM INDS INC

FDA Drug Application

Application #018374

Documents

• Label: 2017-03-06
• Letter: 2017-03-08
• Label: 2018-02-12
• Letter: 2018-02-14
• Letter: 2020-07-30
• Label: 2020-07-30
• Label: 2021-05-24
• Letter: 2021-05-24

Application Sponsors

NDA 018374

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

BACTRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1981-06-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1981-09-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-05-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-09-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-03-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-03-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-04-02	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1984-11-23
LABELING; Labeling	SUPPL	11	AP	1987-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-07-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-08-05	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1987-08-11
LABELING; Labeling	SUPPL	15	AP	1996-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-11-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-06-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1991-11-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-08-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-10-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2001-09-13	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2017-03-04	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-02-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-07-29	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-05-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	15
SUPPL	26	Null	6
SUPPL	27	Null	7
SUPPL	28	Null	7

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18374
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"80MG\/ML;16MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018374s027lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018374s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018374s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BACTRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"80MG\/ML;16MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-29
        )

)