BLA 021271

BAUSCH

FDA Drug Application

Application #021271

Documents

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

Application Sponsors

BLA 021271

BAUSCH

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

15MG/VIAL

0

IPRIVASK

DESIRUDIN RECOMBINANT

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2003-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-07-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-05-18	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	0

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21271
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRIVASK","activeIngredients":"DESIRUDIN RECOMBINANT","strength":"15MG\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/07\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021271s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021271lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IPRIVASK","submission":"DESIRUDIN RECOMBINANT","actionType":"15MG\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-11-07
        )

)