Application Sponsors
ANDA 208266 | PAR STERILE PRODUCTS | |
Marketing Status
None (Tentative Approval) | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | 0 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | 0 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-09-15 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 208266
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 200MCG BASE\/50ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 400MCG BASE\/100ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-09-15
)
)