ANDA 089335

AM REGENT

FDA Drug Application

Application #089335

Application Sponsors

ANDA 089335

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.2MG/ML

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

	ORIG	1	AP	1986-07-23
LABELING; Labeling	SUPPL	2	AP	1988-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-03-04
LABELING; Labeling	SUPPL	6	AP	1990-01-25
LABELING; Labeling	SUPPL	7	AP	1990-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-06-23
LABELING; Labeling	SUPPL	15	AP	2006-09-26
LABELING; Labeling	SUPPL	23	AP	2019-09-04	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	23	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89335
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYCOPYRROLATE","submission":"GLYCOPYRROLATE","actionType":"0.2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)