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 25 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINELIDOCAINEAlembic Pharmaceuticals Inc.11a8b27a-1e25-46e5-bc23-ae5c894b4da42023-10-30Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
generic name: LIDOCAINE
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsName fallback
generic name: LIDOCAINE
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger CotsLIDOCAINECVS PHARMACY, INC82aa128a-44cd-4907-b0f7-8a31e086d3e62023-10-25WarningsName fallback
generic name: LIDOCAINE
Assured Bikini Smooth CreamLIDOCAINEZhejiang Jingwei Pharmaceutical Co., Ltd.fb9ddde3-3f40-467e-8aff-26570144f0fc2023-10-25WarningsName fallback
generic name: LIDOCAINE
Lidocaine 5%LIDOCAINEApnar Pharma LPceedce20-5723-5a9a-e053-2a95a90a17a12023-10-21WarningsName fallback
generic name: LIDOCAINE
Microcaine Topical AnalgesicLIDOCAINEUnit Dose, Ltd.5e8fa8b5-0524-4201-91e1-83e59a8f04152023-10-19WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEBryant Ranch Prepack6fe7721d-42b3-4284-936b-a448ca530c452023-09-14Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINESeptodont, Inc.82a4c16f-d47e-479f-8f85-7d1be6fc23182023-07-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEProficient Rx LP2b9150ea-a876-4511-8d5b-aa72507ef8632023-06-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86083fea-c064-4ef7-e053-2a91aa0ac17c2023-05-16Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86093c75-6dde-bb16-e053-2991aa0ab6ef2023-05-16Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsName fallback
generic name: LIDOCAINE
lidocaineLIDOCAINEAsclemed USA, Inc.58c9afe4-dc36-4f71-8e76-8dff63dc35fb2023-03-27Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEBryant Ranch Prepacka134c265-4fb6-4c78-b9cc-fae8f1fff1cf2023-03-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEBryant Ranch Prepack68bc320f-2871-45b9-815e-bb26081e82492023-03-02Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEBryant Ranch Prepackda9707e2-f830-45e2-a300-1f99cf3dd3622023-02-20Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEQUAGEN PHARMACEUTICALS LLCf8789807-cc0c-485c-aa98-1bdc39337deb2023-02-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
lidocaineLIDOCAINEProficient Rx LP8a85ea77-91ad-4222-9bfe-2ffaf73182e82022-11-01Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEAsclemed USA, Inc.80dadfb5-cbe6-475f-9980-a1b2559827532022-10-12Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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