ANDA 209382

PAR STERILE PRODUCTS

FDA Drug Application

Application #209382

Documents

• Letter: 2019-01-22

Application Sponsors

ANDA 209382

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	1MG/ML	0	TREPROSTINIL	TREPROSTINIL
002	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	2.5MG/ML	0	TREPROSTINIL	TREPROSTINIL
003	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	5MG/ML	0	TREPROSTINIL	TREPROSTINIL
004	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	10MG/ML	0	TREPROSTINIL	TREPROSTINIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-10-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209382
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"1MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"10MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209382Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-24
        )

)