Documents
Application Sponsors
ANDA 208421 | ACCORD HLTHCARE INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2017-10-19 | STANDARD |
Submissions Property Types
CDER Filings
ACCORD HLTHCARE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208421
[companyName] => ACCORD HLTHCARE INC
[docInserts] => ["",""]
[products] => [{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/850MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"2.5MG\/1000MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/19\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208421Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-10-19
)
)