ANDA 206607

MYLAN LABS LTD

FDA Drug Application

Application #206607

Application Sponsors

ANDA 206607

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

80MG/ML;16MG/ML

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-09-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	31

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206607
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"80MG\/ML;16MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-30
        )

)