ANDA 206648

TEVA PHARMS USA

FDA Drug Application

Application #206648

Application Sponsors

ANDA 206648

TEVA PHARMS USA

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

2019-09-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

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

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206648
            [companyName] => TEVA PHARMS USA
            [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\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-26
        )

)