ANDA 210662

BRECKENRIDGE

FDA Drug Application

Application #210662

Application Sponsors

ANDA 210662

BRECKENRIDGE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	250MG	0	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE
002	CAPSULE;ORAL	500MG	0	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210662
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRACYCLINE HYDROCHLORIDE","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRACYCLINE HYDROCHLORIDE","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-07
        )

)