Documents
Application Sponsors
| NDA 208574 | TEVA PHARMS USA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 10MG/2ML (5MG/ML) | 1 | ROMIDEPSIN | ROMIDEPSIN |
| 002 | SOLUTION;INTRAVENOUS | 27.5MG/5.5ML (5MG/ML) | 1 | ROMIDEPSIN | ROMIDEPSIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2020-03-13 | STANDARD |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2020-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-12-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| ORIG | 2 | Null | 15 |
| SUPPL | 6 | Null | 6 |
CDER Filings
TEVA PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208574
[companyName] => TEVA PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"ROMIDEPSIN","activeIngredients":"ROMIDEPSIN","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ROMIDEPSIN","activeIngredients":"ROMIDEPSIN","strength":"27.5MG\/5.5ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/13\/2020","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574Orig2lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/13\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574Orig2lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208574Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/208574Orig1s000,Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"03\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208574s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208574Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/208574Orig1s000,Orig2s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-03-13
)
)