Documents
Application Sponsors
ANDA 204135 | BRECKENRIDGE PHARMS | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;ORAL | 17.5G;3.13G;1.6G | 0 | SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE | SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2016-11-14 | |
Submissions Property Types
CDER Filings
BRECKENRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 204135
[companyName] => BRECKENRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"17.5G;3.13G;1.6G","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/14\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204135Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-11-14
)
)