ANDA 214897

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214897

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 214897

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	65.5MG	0	AMANTADINE	AMANTADINE
002	CAPSULE, EXTENDED RELEASE;ORAL	137MG	0	AMANTADINE	AMANTADINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-09-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214897
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE","activeIngredients":"AMANTADINE","strength":"65.5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"AMANTADINE","activeIngredients":"AMANTADINE","strength":"137MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-29
        )

)