NDA 208144

BAUSCH AND LOMB INC

FDA Drug Application

Application #208144

Documents

• Letter: 2017-12-22
• Label: 2017-12-28
• Review: 2018-04-09
• Pediatric Medical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2019-02-22
• Label: 2019-03-01
• Letter: 2019-05-02
• Label: 2019-05-02
• Label: 2020-03-06
• Letter: 2020-03-06
• Letter: 2020-09-25
• Letter: 2021-11-30
• Label: 2022-02-14

Application Sponsors

NDA 208144

BAUSCH AND LOMB INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.025%

1

LUMIFY

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-12-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-04-30	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-03-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-09-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	6	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	7

CDER Filings

BAUSCH AND LOMB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208144
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMIFY","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.025%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208144Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208144Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-Facility","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208144Orig1s001lbl_REPLACEMENT.pdf\"}]","notes":""},{"actionDate":"12\/22\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208144Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/2017","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\\\/2017\\\/208144Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208144Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208144Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208144Orig1s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208144Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208144Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208144Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/21\/2019","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-Facility","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208144Orig1s001lbl_REPLACEMENT.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208144Orig1s001ltr_REPLACEMENT.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-05
        )

)