ANDA 214553

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214553

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 214553

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

GEL;TOPICAL

0.3%;2.5%

0

ADAPALENE AND BENZOYL PEROXIDE

ADAPALENE; BENZOYL PEROXIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-10-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214553
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE; BENZOYL PEROXIDE","activeIngredients":"ADAPALENE;BENZOYL PEROXIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-07
        )

)