ANDA 209522

TEVA PHARMS USA

FDA Drug Application

Application #209522

Documents

• Letter: 2019-05-22

Application Sponsors

ANDA 209522

TEVA PHARMS USA

Marketing Status

• Discontinued: 001

Application Products

001

SPRAY, METERED;NASAL

4MG/SPRAY

0

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209522
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"4MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209522Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-19
        )

)