NDA 208135

ALCON LABS

FDA Drug Application

Application #208135

Documents

• Letter: 2016-03-02
• Label: 2016-03-03
• Review: 2016-10-27
• Summary Review: 2016-10-27
• Pediatric DD Summary Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2022-03-01
• Label: 2022-03-02

Application Sponsors

NDA 208135

ALCON LABS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;OPHTHALMIC

0.5%

1

TETRACAINE HYDROCHLORIDE

TETRACAINE HYDROCHLORIDE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2016-02-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-02-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

CDER Filings

ALCON LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208135
            [companyName] => ALCON LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRACAINE HYDROCHLORIDE","activeIngredients":"TETRACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208135s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208135s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208135Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208135Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208135Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-02-29
        )

)