FDA.reportPublic FDA data

Application 208786

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;INTRAVENOUS37.5MG/ML (37.5MG/ML)NoNo

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
A208786-001DICLOFENAC SODIUMDICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18

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 22:38:342026-08A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1884e616aacf4f…
2026-08-18 06:07:402026-07A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-183f01610625f2…
2019-09-15 20:21 UTC2019-09A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208786-001DICLOFENAC SODIUM37.5MG/ML (37.5MG/ML)SOLUTION / INTRAVENOUS2019-06-18f41ea6bd6efb…

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 4 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.06862cf2-9537-6661-e063-6294a90a20842026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack03c4f06f-6a49-4404-bf3b-0aafa33c81ef2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMRugby Laboratories95f3c70c-eded-4d24-b9b0-cfa0b7902d6e2026-02-10WarningsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Sportpharm LLCa133d18e-981d-43b7-bef1-7869f7c7d9a72026-02-09WarningsName fallback
brand name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMREMEDYREPACK INC.6aab6c1f-9b02-4101-b7c8-ab7a557043202026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMSOLA Pharmaceuticals, LLC11e88ced-cdcf-4101-9297-c4c3dde9d0892026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMSportpharm LLC99f1e69e-02cf-49c2-83af-3cccbbea42152026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMUmedica Laboratories USA Inc.0e5c6669-390f-4c32-b9b8-13ed3c5174622026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMFamily Dollar (FAMILY WELLNESS)03ddf347-a3a3-4313-87d1-a246c1d4e0b42026-01-29WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMBausch & Lomb Incorporated39dfffb0-612a-48f3-8db5-1a59899b91e92026-01-27Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMIngenus Pharmaceuticals, LLC1a237198-ca24-4159-b570-b5a23c8e91b02026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DICLOFENAC SODIUM
generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMPublix Super Markets Incbae07276-c800-468e-a201-e6268846fff32026-01-15WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium
generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59237ORIG2019-07-05