ANDA 212845

SOLARIS PHARMA CORP

FDA Drug Application

Application #212845

Documents

• Letter: 2022-08-09

Application Sponsors

ANDA 212845

SOLARIS PHARMA CORP

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1.2%;0.025%

0

CLINDAMYCIN PHOSPHATE AND TRETINOIN

CLINDAMYCIN PHOSPHATE; TRETINOIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB2

CDER Filings

SOLARIS PHARMA CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212845
            [companyName] => SOLARIS PHARMA CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND TRETINOIN","activeIngredients":"CLINDAMYCIN PHOSPHATE; TRETINOIN","strength":"1.2%;0.025%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-10
        )

)