Application Sponsors
ANDA 205365 | ANI PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 7MG | 0 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | 0 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | 0 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE |
004 | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | 0 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-02-28 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205365
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-02-28
)
)