ANDA 205229

XIROMED

FDA Drug Application

Application #205229

Application Sponsors

ANDA 205229

XIROMED

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	100MG	0	PROGESTERONE	PROGESTERONE
002	CAPSULE;ORAL	200MG	0	PROGESTERONE	PROGESTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205229
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-20
        )

)