Documents
Application Sponsors
ANDA 205379 | ACCORD HLTHCARE | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 40MG BASE/VIAL | 0 | ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-09-25 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-04-17 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-04-17 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2020-04-17 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-04-17 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-04-17 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
SUPPL | 7 | Null | 7 |
TE Codes
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 205379
[companyName] => ACCORD HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/25\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205379Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205379Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205379Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-17
)
)