ANDA 208358

CADILA

FDA Drug Application

Application #208358

Application Sponsors

ANDA 208358

CADILA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

25MG;37.5MG

0

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208358
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-11
        )

)