Application Sponsors
ANDA 200432 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 12.5MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
002 | TABLET;ORAL | 25MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
003 | TABLET;ORAL | 50MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2022-02-17 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
003 | Prescription | AA |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 200432
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)