NDA 201110

Ferring Pharmaceuticals, Inc.

FDA Drug Application

Application #201110

Documents

• Letter: 2020-04-30
• Label: 2020-04-30
• Review: 2020-07-16

Application Sponsors

NDA 201110

Ferring Pharmaceuticals, Inc.

Marketing Status

• Prescription: 001

Application Products

001

RING;VAGINAL

1.78g

0

MILPROSA

PROGESTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

FERRING PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201110
            [companyName] => FERRING PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILPROSA","activeIngredients":"PROGESTERONE","strength":"1.78GM","dosageForm":"SYSTEM;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/29\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201110s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201110s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201110Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/201110Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-29
        )

)