NDA 021076

BAYER

FDA Drug Application

Application #021076

Documents

• Letter: 1999-11-29
• Letter: 2002-07-31
• Label: 1999-11-29
• Other Important Information from FDA: 2005-07-28
• Letter: 2006-01-20
• Letter: 2008-08-06
• Letter: 2009-04-21
• Review: 2004-05-26
• Letter: 2017-09-15
• Label: 2017-09-21
• Label: 2020-04-07
• Letter: 2020-04-07
• Letter: 2022-03-03
• Label: 2022-03-03

Application Sponsors

NDA 021076

BAYER

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

220MG;120MG

1

ALEVE-D SINUS & COLD

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1999-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-12-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-07-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	2006-01-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-08-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-04-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2017-09-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-04-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-03-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	7

CDER Filings

BAYER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21076
            [companyName] => BAYER
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALEVE-D SINUS & COLD","activeIngredients":"NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"220MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021076Orig1s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021076Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/21-076_Aleve_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALEVE-D SINUS & COLD","submission":"NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"220MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-06
        )

)