NDA 020696

PAR PHARM INC

FDA Drug Application

Application #020696

Documents

• Letter: 2000-12-08
• Label: 2020-12-28
• Letter: 2020-12-29

Application Sponsors

NDA 020696

PAR PHARM INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1.5GM/1.5ML (1GM/ML)

1

ANTIZOL

FOMEPIZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-12-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-23	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5	Null	14
SUPPL	6	Null	6

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20696
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANTIZOL","activeIngredients":"FOMEPIZOLE","strength":"1.5GM\/1.5ML (1GM\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/23\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020696Orig1s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANTIZOL","submission":"FOMEPIZOLE","actionType":"1.5GM\/1.5ML (1GM\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-12-23
        )

)