NDA 210821

BAUSCH

FDA Drug Application

Application #210821

Documents

• Label: 2019-03-13
• Letter: 2019-03-14
• Review: 2019-04-18
• Letter: 2022-02-23
• Label: 2022-02-25

Application Sponsors

NDA 210821

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;OPHTHALMIC

0.5%

0

TETRACAINE HYDROCHLORIDE

TETRACAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-03-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-02-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210821
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRACAINE HYDROCHLORIDE","activeIngredients":"TETRACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/12\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210821s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210821s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210821Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210821Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-03-12
        )

)