ANDA 091602

CIPLA

FDA Drug Application

Application #091602

Application Sponsors

ANDA 091602

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/VIAL

0

BIVALIRUDIN

BIVALIRUDIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2018-07-16
LABELING; Labeling	SUPPL	5	AP	2019-09-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91602
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)