Application Sponsors
ANDA 211574 | ALEMBIC GLOBAL HOLDING SA | |
Marketing Status
None (Tentative Approval) | 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 | TA | 2020-09-03 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
004 | Prescription | AP |
CDER Filings
ALEMBIC GLOBAL HOLDING SA
cder:Array
(
[0] => Array
(
[ApplNo] => 211574
[companyName] => ALEMBIC GLOBAL HOLDING SA
[docInserts] => ["",""]
[products] => [{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/03\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-03
)
)