ANDA 089595

CMP PHARMA INC

FDA Drug Application

Application #089595

Application Sponsors

ANDA 089595

CMP PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

TRIAMCINOLONE ACETONIDE IN ABSORBASE

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1995-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-04-20
LABELING; Labeling	SUPPL	4	AP	2017-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2021-07-28	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	8	Null	31

TE Codes

001

Prescription

AT

CDER Filings

CMP PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89595
            [companyName] => CMP PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE IN ABSORBASE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE IN ABSORBASE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)