Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 50MG/10ML (5MG/ML) | 1 | PROVAYBLUE | METHYLENE BLUE |
| 002 | SOLUTION;INTRAVENOUS | 10MG/2ML (5MG/ML) | 1 | PROVAYBLUE | METHYLENE BLUE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2016-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-12-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2021-12-03 | N/A |
| LABELING; Labeling | SUPPL | 10 | TA | 2020-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-05-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2022-07-13 | N/A |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-08-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 10 | Orphan | 5 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 18 | Null | 15 |
CDER Filings
PROVEPHARM SAS
cder:Array
(
[0] => Array
(
[ApplNo] => 204630
[companyName] => PROVEPHARM SAS
[docInserts] => ["",""]
[products] => [{"drugName":"PROVAYBLUE","activeIngredients":"METHYLENE BLUE","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PROVAYBLUE","activeIngredients":"METHYLENE BLUE","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204630s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204630s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204630s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204630s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204630Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/204630Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/204630Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204630s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204630Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/29\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204630s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204630Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-05-21
)
)