Documents
Application Sponsors
| NDA 208083 | BAXTER HLTHCARE CORP | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | EQ 300MG BASE/50ML (EQ 6MG BASE/ML) | 1 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE |
| 002 | SOLUTION;INTRAVENOUS | EQ 600MG BASE/50ML (EQ 12MG BASE/ML) | 1 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE |
| 003 | SOLUTION;INTRAVENOUS | EQ 900MG BASE/50ML (EQ 18MG BASE/ML) | 1 | CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-09-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
CDER Filings
BAXTER HLTHCARE CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 208083
[companyName] => BAXTER HLTHCARE CORP
[docInserts] => ["",""]
[products] => [{"drugName":"CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 300MG BASE\/50ML (EQ 6MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 600MG BASE\/50ML (EQ 12MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 900MG BASE\/50ML (EQ 18MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/01\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208083s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208083lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/20\/2017","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\\\/2017\\\/208083lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208083Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208083Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/01\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208083s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208083Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","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] => 2019-08-01
)
)