ANDA 090963

HIKMA FARMACEUTICA

FDA Drug Application

Application #090963

Application Sponsors

ANDA 090963

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.2MG/ML

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

	ORIG	1	AP	2011-09-21
LABELING; Labeling	SUPPL	12	AP	2019-08-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	12	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90963
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYCOPYRROLATE","submission":"GLYCOPYRROLATE","actionType":"0.2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)