ANDA 077612

ANI PHARMS INC

FDA Drug Application

Application #077612

Documents

• Label: 2014-02-06

Application Sponsors

ANDA 077612

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML;40MG/5ML

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

	ORIG	1	AP	2006-11-13
LABELING; Labeling	SUPPL	2	AP	2007-11-01
LABELING; Labeling	SUPPL	5	AP	2012-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2021-10-25	UNKNOWN

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77612
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"200MG\/5ML;40MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/13\/2012","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/077612s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"200MG\/5ML;40MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-08-13
        )

)