NDA 210134

ELI LILLY AND CO

FDA Drug Application

Application #210134

Documents

• Label: 2019-07-24
• Letter: 2019-07-25
• Review: 2019-11-25
• Pediatric Medical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2020-10-29
• Letter: 2020-11-02

Application Sponsors

NDA 210134

ELI LILLY AND CO

Marketing Status

• Prescription: 001

Application Products

001

POWDER;NASAL

3MG

1

BAQSIMI

GLUCAGON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-07-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-10-27	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

ELI LILLY AND CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210134
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"BAQSIMI","activeIngredients":"GLUCAGON","strength":"3MG","dosageForm":"POWDER;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/24\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210134s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/24\/2019","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\\\/2019\\\/210134s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210134Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210134Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-07-24
        )

)