NDA 206276

NOVARTIS

FDA Drug Application

Application #206276

Documents

• Letter: 2015-02-11
• Label: 2015-03-27
• Review: 2015-04-13
• Review: 2016-02-03
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-07-17
• Label: 2020-07-17
• Label: 2022-01-05
• Review: 2022-04-07

Application Sponsors

NDA 206276

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.7% BASE

1

PAZEO

OLOPATADINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2015-01-30	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2020-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2021-10-25	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

CDER Filings

ALCON LABS INC

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(
    [0] => Array
        (
            [ApplNo] => 206276
            [companyName] => ALCON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PATADAY ONCE DAILY RELIEF","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.7% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/25\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/206276Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206276Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206276s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206276s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206276Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206276Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/25\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/206276Orig1s006lbl.pdf\"}]","notes":">"},{"actionDate":"07\/13\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206276Orig1s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206276Orig1s005ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/206276Orig1s005.pdf\"}]","notes":">"},{"actionDate":"11\/27\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206276Orig1s001.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-10-25
        )

)