ANDA 090811

HOSPIRA INC

FDA Drug Application

Application #090811

Documents

• Label: 2015-07-16
• Letter: 2015-07-15

Application Sponsors

ANDA 090811

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/VIAL

0

BIVALIRUDIN

BIVALIRUDIN

FDA Submissions

	ORIG	1	AP	2015-07-14
LABELING; Labeling	SUPPL	3	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90811
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/14\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/090811s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BIVALIRUDIN","submission":"BIVALIRUDIN","actionType":"250MG\/VIAL","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-07-14
        )

)