FDA.reportPublic FDA data

Application 206276

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAZEOOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.7% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0816PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-0816PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-0816PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-0816PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.NDACurrent
0065-4273Pazeoolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4273Pazeoolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4273Pazeoolopatadine hydrochlorideAlcon Laboratories, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82102SUPPL 2025-05-01
81937SUPPL 2025-04-21
70731SUPPL2022-04-07
69809SUPPL2022-01-05
63960SUPPL2020-07-17
63959SUPPL2020-07-17
43511SUPPL2016-02-03
23018ORIG2015-04-13
19711ORIG2015-03-27
10554ORIG2015-02-11
51448ORIG1900-01-01
51447ORIG1900-01-01
51446ORIG1900-01-01