ANDA 216690

PAR STERILE PRODUCTS

FDA Drug Application

Application #216690

Application Sponsors

ANDA 216690

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/VIAL

0

DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216690
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-07
        )

)