NDA 211733

PFIZER INC

FDA Drug Application

Application #211733

Documents

• Label: 2020-02-28
• Letter: 2020-02-28
• Review: 2020-03-31
• Label: 2022-01-11
• Letter: 2022-01-11
• Letter: 2022-01-27
• Label: 2022-02-03

Application Sponsors

NDA 211733

PFIZER INC

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

250MG;125MG

1

ADVIL DUAL ACTION WITH ACETAMINOPHEN

ACETAMINOPHEN; IBUPROFEN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2020-02-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-01-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211733
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL DUAL ACTION WITH ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; IBUPROFEN","strength":"250MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211733Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211733Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211733Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/211733Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-02-28
        )

)