Documents
Application Sponsors
NDA 211363 | INTL MEDICATION SYS | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1MG/10ML(0.1MG/ML) | 0 | EPINEPHRINE | EPINEPHRINE |
FDA Submissions
TYPE 7; Type 7 - Drug Already Marketed without Approved NDA | ORIG | 1 | AP | 2022-08-15 | STANDARD |
Submissions Property Types
CDER Filings
INTL MEDICATION SYS
cder:Array
(
[0] => Array
(
[ApplNo] => 211363
[companyName] => INTL MEDICATION SYS
[docInserts] => ["",""]
[products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"1MG\/10ML(0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/211363Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-08-15
)
)