FDA.reportPublic FDA data

Application 021862

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEVANACNEPAFENACSUSPENSION/DROPS;OPHTHALMIC0.1%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021862-001NEVANACNEPAFENAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021862-00178340592027-01-31U-10952010-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N021862-00178340592027-01-31U-10952010-11-30c2088c7a36db…
2026-09-14 22:38:342026-08N021862-00178340592027-01-31U-10952010-11-3084e616aacf4f…
2026-08-18 06:07:402026-07N021862-00178340592027-01-31U-10952010-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021862-00178340592027-01-31U-10952010-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00180716482025-12-02Drug product2011-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00183242812025-12-02Drug product2012-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00178340592027-01-31U-10952010-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021862-00180716482025-12-02Drug product2011-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021862-00183242812025-12-02Drug product2012-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021862-00178340592027-01-31U-10952010-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00180716482025-12-02Drug product2011-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00183242812025-12-02Drug product2012-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00178340592027-01-31U-10952010-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00180716482025-12-02Drug product2011-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00183242812025-12-02Drug product2012-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00178340592027-01-31U-10952010-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00180716482025-12-02Drug product2011-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00183242812025-12-02Drug product2012-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00178340592027-01-31U-10952010-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00180716482025-12-02Drug product2011-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00183242812025-12-02Drug product2012-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00178340592027-01-31U-10952010-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00180716482025-12-02Drug product2011-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00183242812025-12-02Drug product2012-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00178340592027-01-31U-10952010-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00180716482025-12-02Drug product2011-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00183242812025-12-02Drug product2012-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00178340592027-01-31U-10952010-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021862-00180716482025-12-02Drug product2011-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021862-00183242812025-12-02Drug product2012-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021862-00178340592027-01-31U-10952010-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00180716482025-12-02Drug product2011-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00183242812025-12-02Drug product2012-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00178340592027-01-31U-10952010-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00180716482025-12-02Drug product2011-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00183242812025-12-02Drug product2012-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00178340592027-01-31U-10952010-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00180716482025-12-02Drug product2011-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00183242812025-12-02Drug product2012-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00178340592027-01-31U-10952010-11-301e350fbaab3a…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEVANACNEPAFENACHarrow Eye, LLC11b9a0cf-2a70-17ef-e063-6394a90a5d9e2024-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021862
application number: NDA021862

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0065-0002NEVANACnepafenacAlcon Laboratories, Inc.NDACurrent
0078-0778NEVANACnepafenacNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65162SUPPL2020-11-09
65158SUPPL2020-11-05
50832SUPPL2017-12-22
50781SUPPL2017-12-20
6329SUPPL2011-07-05
16477SUPPL2011-06-27
37780SUPPL2008-06-12
42331ORIG2005-10-06
16476ORIG2005-08-23
6328ORIG2005-08-23