ANDA 090747

AM REGENT

FDA Drug Application

Application #090747

Application Sponsors

ANDA 090747

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3MG/ML;EQ 3MG BASE/ML

0

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	2009-07-31
LABELING; Labeling	SUPPL	4	AP	2016-04-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2022-01-13	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	18	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90747
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE","activeIngredients":"BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE","strength":"3MG\/ML;EQ 3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE","submission":"BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE","actionType":"3MG\/ML;EQ 3MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)