FDA.reportPublic FDA data

Application 217221

Type
ANDA
Sponsor
DIFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEPATCH;TOPICAL1.8%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
A217221-001LIDOCAINELIDOCAINE1.8%PATCH / TOPICALAB2025-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217221-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217221-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217221-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217221-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217221-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217221-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217221-001AB1a50c72e98297…

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 26 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lidocaineLIDOCAINEProficient Rx LPf9b290d2-0e24-4ca8-bca2-3016f5c404df2022-05-01Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEActavis Pharma, Inc.4d04052c-3e0a-469a-9265-99604f13e5072022-04-30Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEProficient Rx LP2c396307-cf12-41d0-89e6-0f4ec74df55e2022-04-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEAVKAREec6a4720-9821-c0fc-e053-2995a90a05df2022-04-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
lidocaineLIDOCAINEGlenmark Pharmaceuticals Inc., USAeaa15be7-11ea-49bc-ac07-739075453be62021-08-20Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
lidocaineLIDOCAINEAsclemed USA, Inc.6abf3773-0e60-48b1-9d5c-adc590363d132021-08-09Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEProficient Rx LPf1007717-528a-42e2-94aa-db0edf3bb6032021-01-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidoxrylLIDOCAINEPureTek Corporation1c33790b-8d57-46e8-bd6e-5a0f87a3c29f2020-11-10Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
LidoPure PatchLIDOCAINEPureTek Corporationc851c6e9-1966-4639-9406-fe6adc91c9d02020-11-10Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAsclemed USA, Inc.c18f0c2b-cd05-4458-888f-47b4a11069372020-11-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEProficient Rx LPcbf01b82-c43f-4bed-a1df-7569f4816c762019-11-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEAmneal Pharmaceuticals LLCd1509740-f9f1-44e3-8fde-51d8683fcd872018-10-28Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Deeveeant NumbLIDOCAINEValekista Limited2d7b39cc-4f1b-4414-b129-88c56e159aba2017-07-06WarningsName fallback
generic name: LIDOCAINE
MediNumbLIDOCAINEValekista Limited0e43648d-3dae-4faf-a6b4-d21c062e32e12017-07-06WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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