Documents
Application Sponsors
| NDA 020444 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 0.5MG BASE/VIAL | 1 | FLOLAN | EPOPROSTENOL SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1.5MG BASE/VIAL | 1 | FLOLAN | EPOPROSTENOL SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-09-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-11-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2000-04-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1999-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2000-09-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-01-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-04-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-06-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-06-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-09-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2011-03-29 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2015-04-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 2018-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2018-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2021-08-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 7 | Null | 14 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 10 | Null | 14 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 21 | Null | 14 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 20444
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"FLOLAN","activeIngredients":"EPOPROSTENOL SODIUM","strength":"EQ 0.5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"FLOLAN","activeIngredients":"EPOPROSTENOL SODIUM","strength":"EQ 1.5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/12\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020444s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020444s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020444s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020444s021lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/29\/2011","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020444s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020444s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2000","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20444S03LBL.PDF\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FLOLAN","submission":"EPOPROSTENOL SODIUM","actionType":"EQ 0.5MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FLOLAN","submission":"EPOPROSTENOL SODIUM","actionType":"EQ 1.5MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-12
)
)