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 42.

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
2026-08-18 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
2026-08-18 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 6 of 26 · 515 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. NumbLIDOCAINEShinpharma Incc2c0cb17-401a-4ba2-aa04-64c9b43cd21b2026-04-30WarningsName fallback
generic name: LIDOCAINE
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLCcffda6fc-7e85-4c48-9623-2551d3552d7d2026-04-24Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.1ca96c77-d983-496b-84a6-54709e80f5322026-04-23Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.f8d90500-f797-4238-8dd2-b59cbcd89d122026-04-23Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEMacleods Pharmaceuticals Limitedc788afd3-4554-40c4-8f26-2c31ab9b9b982026-04-16Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Relivyx PlusLIDOCAINEV2 Pharma LLC08aeb3f5-56ea-4fd7-b151-e6dc65f202da2026-04-16Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
NeurocaineLIDOCAINEBlue Heron Pharmaceuticals LLCf36eaded-3155-480c-8723-4b07b6b0790d2026-04-16WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEPreferred Pharmaceuticals, Inc.e7ed90d7-11c0-4781-a727-1fe3659a29482026-04-15Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
generic name: LIDOCAINE
Walgreens Lidocaine Pain Relieving Patch AssortedLIDOCAINEWalgreen Co.41e98f15-669f-4543-e063-6294a90a1ef72026-04-15WarningsName fallback
generic name: LIDOCAINE
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcare4f112ab2-b67a-a3e2-e063-6394a90acb602026-04-09WarningsName fallback
generic name: LIDOCAINE
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsName fallback
generic name: LIDOCAINE
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-04-06WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain-Relieving PatchLIDOCAINECVS Pharmacy4ed04089-50be-9e01-e063-6394a90a2b3f2026-04-06WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEYYBA Corp5256a84a-8dac-8fd4-e063-6294a90a616c2026-04-01WarningsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
SPARTANLIDOCAINETIV PRIME SRL4e04146a-ed19-2271-e063-6394a90a50f02026-03-27WarningsName fallback
generic name: LIDOCAINE
Walgreens Pain Relieving LidocaineLIDOCAINEWalgreen Co.41d5bdc4-66c8-31ab-e063-6394a90a11952026-03-27WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENovocol Pharmaceutical of Canada, Inc.2005680a-8a23-4403-a618-e4ee74fa11212026-03-26Warnings, Adverse reactionsName fallback
brand name: Lidocaine