ANDA 090850

GLAND PHARMA LTD

FDA Drug Application

Application #090850

Documents

• Review: 2013-01-22

Application Sponsors

ANDA 090850

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-01-25
LABELING; Labeling	SUPPL	2	AP	2012-08-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-10-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90850
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)