Documents
Application Sponsors
| NDA 209510 | ACACIA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 5MG/2ML (2.5MG/ML) | 1 | BARHEMSYS | AMISULPRIDE |
| 002 | SOLUTION;INTRAVENOUS | 10MG/4ML (2.5MG/ML) | 1 | BARHEMSYS | AMISULPRIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2020-09-01 | N/A |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-05-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-09-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
CDER Filings
ACACIA
cder:Array
(
[0] => Array
(
[ApplNo] => 209510
[companyName] => ACACIA
[docInserts] => ["",""]
[products] => [{"drugName":"BARHEMSYS","activeIngredients":"AMISULPRIDE","strength":"5MG\/2ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209510s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209510s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209510Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/209510Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-02-26
)
)