ANDA 088237

XSPIRE PHARMA

FDA Drug Application

Application #088237

Application Sponsors

ANDA 088237

XSPIRE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1.5MG

0

DEXAMETHASONE

DEXAMETHASONE

FDA Submissions

	ORIG	1	AP	1983-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-10-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1983-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-09-16
LABELING; Labeling	SUPPL	17	AP	1989-07-31
LABELING; Labeling	SUPPL	18	AP	1990-01-23
LABELING; Labeling	SUPPL	19	AP	1990-11-20
LABELING; Labeling	SUPPL	20	AP	1992-04-29
LABELING; Labeling	SUPPL	21	AP	1994-04-28
LABELING; Labeling	SUPPL	22	AP	1995-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-11-26
LABELING; Labeling	SUPPL	26	AP	2008-07-24

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0

TE Codes

001

Prescription

BP

CDER Filings

XSPIRE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88237
            [companyName] => XSPIRE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)