Documents
Application Sponsors
| NDA 202106 | B BRAUN MEDICAL INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | 500MG/VIAL | 0 | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | MEROPENEM |
| 002 | POWDER;INTRAVENOUS | 1GM/VIAL | 0 | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | MEROPENEM |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2015-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-05-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 7 | Null | 6 |
CDER Filings
B BRAUN MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202106
[companyName] => B BRAUN MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202106s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202106s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202106lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202106lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202106Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/202106Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/202106Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202106s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202106Orig1s007ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202106Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/19\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202106s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202106Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/15\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Label is not available on this site."}]
[actionDate] => 2020-05-12
)
)