NDA 209405

EXELTIS USA INC

FDA Drug Application

Application #209405

Documents

• Letter: 2020-03-31
• Label: 2020-04-07
• Label: 2020-06-02
• Letter: 2020-06-02
• Review: 2020-09-10
• Label: 2022-05-02
• Letter: 2022-05-04

Application Sponsors

NDA 209405

EXELTIS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

0.02MG;0.1MG

1

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-03-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6

CDER Filings

EXELTIS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209405
            [companyName] => EXELTIS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYBLUME","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG;0.1MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209405s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209405s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209405Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/30\/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\\\/209405Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209405Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209405s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209405Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-05-29
        )

)