FDA.reportPublic FDA data

Application 020037

Type
NDA
Sponsor
NOVARTIS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020037-001VOLTARENDICLOFENAC SODIUM0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICATRLD, RS1991-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020037-001VOLTAREN0.1%SOLUTION/DROPS / OPHTHALMICRLD1991-03-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020037-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020037-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N020037-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020037-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020037-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020037-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N020037-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020037-001AT1ea99ee380514…

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 14 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSandoz Inc52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b2021-09-29Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.a57b897e-0cbe-4ac3-969f-b00357a0cfa82021-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.f3f60cd3-8f1f-4ca4-9621-805b4a6c35a82021-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMAsclemed USA, Inc.57d8513a-820a-46c5-b0c8-5aa1811b0e882020-10-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP20107264-e533-4de9-9a37-59fde7981c922020-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.1e39f8d4-56a2-4d29-a971-495574e8d4a72020-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP7bc185e2-e749-4a24-8550-c2f6d39222d22020-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb0f9e649-6651-406f-a9fe-157fe04d9d272020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPa7447467-79e0-436e-a273-d1ddd06169cf2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP77c3cb56-c071-4d92-a0d6-022417a27de42019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAphena Pharma Solutions - Tennessee, LLCe4af374a-1281-46af-a0a9-48820db6c9472018-05-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMNovel Laboratories, Inc.c99f5ef6-c777-4896-a5e7-7335257439b22016-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0478VOLTARENdiclofenac sodiumNovartis Pharmaceutical CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34203SUPPL2012-09-14
1945SUPPL2012-09-14
21072SUPPL2011-04-13
34202SUPPL2011-04-11
21071SUPPL2007-09-06
12159SUPPL2007-09-06