BLA 021716

AKORN INC

FDA Drug Application

Application #021716

Documents

• Letter: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-25

Application Sponsors

BLA 021716

AKORN INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

150 UNITS/ML

0

HYDASE

HYALURONIDASE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2005-10-25	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2015-11-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	31

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21716
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDASE","activeIngredients":"HYALURONIDASE","strength":"150 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/05\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021716s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021716lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDASE","submission":"HYALURONIDASE","actionType":"150 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-11-05
        )

)