FDA.reportPublic FDA data

Application 020688

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PATADAY TWICE DAILY RELIEFOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0271Patanololopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0271Patanololopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0271Patanololopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4274PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-4274PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-4274PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-4274PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
50090-0593Patanololopatadine hydrochlorideA-S Medication SolutionsNDACurrent
61314-271olopatadine hydrochlorideolopatadine hydrochlorideSandoz Inc.NDA AUTHORIZED GENERICCurrent
61314-271olopatadine hydrochlorideolopatadine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-271olopatadine hydrochlorideolopatadine hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82100SUPPL 2025-05-01
81935SUPPL 2025-04-21
70717SUPPL2022-04-07
64782SUPPL2020-10-01
61901SUPPL2020-02-14
61898SUPPL2020-02-14
41556SUPPL2008-08-08
41555SUPPL2008-08-08
41554SUPPL2008-08-08
20824SUPPL2008-08-08
20823SUPPL2008-08-08
20822SUPPL2008-08-08
20821SUPPL2008-08-08
20820SUPPL2008-08-08
41557SUPPL2008-08-04
20825SUPPL2008-08-04
13208SUPPL2003-05-29
3085SUPPL2003-05-29
25513SUPPL2000-03-20
57464ORIG1997-04-11