FDA.reportPublic FDA data

Application 021545

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.2% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0272PATADAYolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0272PATADAYolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0272PATADAYolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-8150PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
61314-272Olopatadine HydrochlorideOlopatadine HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-272Olopatadine HydrochlorideOlopatadine HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-272Olopatadine HydrochlorideOlopatadine HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82101SUPPL 2025-05-01
81936SUPPL 2025-04-21
70718SUPPL2022-04-07
68283SUPPL2021-08-04
64783SUPPL2020-10-01
61900SUPPL2020-02-14
61899SUPPL2020-02-14
28080SUPPL2010-12-10
37196SUPPL2010-12-08
5692SUPPL2007-06-14
5691SUPPL2007-06-14
37195SUPPL2007-06-12
37194SUPPL2007-06-12
28079SUPPL2007-05-01
15739SUPPL2007-05-01
21728ORIG2007-02-20
15738ORIG2004-12-29
5690ORIG2004-12-29