FDA.reportPublic FDA data

Application 205352

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALEVE PMDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUMTABLET;ORAL25MG;220MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-1200Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70133SUPPL2022-02-09
70132SUPPL2022-02-09
65385SUPPL2020-11-30
65132SUPPL2020-11-03
62463SUPPL2020-04-07
62462SUPPL2020-04-07
58288SUPPL2019-04-11
58287SUPPL2019-04-11
55352SUPPL2018-08-29
55347SUPPL2018-08-28
51080SUPPL2018-01-18
51075SUPPL2018-01-17
49820SUPPL2017-09-21
49754SUPPL2017-09-15
32659SUPPL2015-12-30
32658SUPPL2015-10-30
40462SUPPL2015-10-29
19635SUPPL2015-08-26
32657SUPPL2015-08-18
19634SUPPL2015-07-22
10437SUPPL2015-07-16
44916ORIG2015-05-14
22982ORIG2015-05-14
40461SUPPL2015-03-12
32656SUPPL2015-02-27
40460SUPPL2015-01-08
32655SUPPL2014-11-24
19633SUPPL2014-09-23
32654SUPPL2014-09-03
19632ORIG2014-01-28
10436ORIG2014-01-17
51396ORIG1900-01-01
51395ORIG1900-01-01
51394ORIG1900-01-01