FDA.reportPublic FDA data

Application 076320

Type
ANDA
Sponsor
TOLMAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINECREAM;TOPICAL2.5%;2.5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076320-001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2003-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076320-001AB

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076320-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2003-08-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076320-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2003-08-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076320-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2003-08-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076320-001LIDOCAINE AND PRILOCAINE2.5%;2.5%CREAM / TOPICALAB2003-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A076320-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A076320-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A076320-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076320-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076320-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076320-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076320-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076320-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076320-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076320-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076320-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076320-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076320-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076320-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076320-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076320-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076320-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076320-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076320-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076320-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076320-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076320-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076320-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076320-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076320-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076320-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076320-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076320-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076320-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076320-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076320-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076320-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076320-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076320-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076320-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076320-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076320-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076320-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076320-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076320-001AB13a93d1ddd44b…

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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEPreferred Pharmaceuticals Inc.69fed044-a6b8-40a7-9ba1-7fb10435ca742026-05-21Warnings, Adverse reactionsName fallback
brand name: Lidocaine and Prilocaine
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEPadagis US LLC6e1635f7-dcae-441b-bbf7-495661fb66ae2026-03-30Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEPreferred Pharmaceuticals Inc.82111bef-460f-4948-a19c-1d2063427ee42026-03-17Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC833cd52c-6470-49c4-937f-1393971f4db92026-01-28Warnings, Adverse reactionsName fallback
brand name: Lidocaine and Prilocaine
Lidocaine and prilocaineLIDOCAINE AND PRILOCAINEViona Pharmaceuticals Inc0a3b26d3-7a32-4403-88ab-0924356b52142025-12-01Warnings, Adverse reactionsName fallback
brand name: Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack3cd9a055-8b9b-4dff-967b-54023df72e432025-10-21Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack889a8ba8-4058-49e1-8b28-08a3afbf280f2025-10-21Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack5bee9fab-a493-448e-b68c-fb58156d49b62025-07-28Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINENuCare Pharmaceuticals, Inc.365e59a2-b970-2ab1-e063-6294a90acfa92025-05-30Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEAlembic Pharmaceuticals Limited54198bf6-c93c-42cd-9b2b-63918eb328802025-04-08Warnings, Adverse reactionsName fallback
brand name: Lidocaine and Prilocaine
Lidocaine and prilocaineLIDOCAINE AND PRILOCAINEZydus Lifesciences Limitedf85ec4ed-4a1b-4680-ace1-b2a0b1114af52024-12-30Name fallback
brand name: Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEBryant Ranch Prepack2cd9f2a5-3726-4c74-b561-1555faf8ea882024-11-11Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINENuCare Pharamceuticals,Inc.5900691d-8b50-7752-e053-2991aa0a5c5c2024-07-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine and Prilocaine
LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEA-S Medication Solutionsa4c310f5-e83e-4e40-a73d-818da5f49fec2023-08-17Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE AND PRILOCAINE
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEAlembic Pharmaceuticals Inc.7851790a-f2f3-4d65-9785-f77feafa8d932023-08-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine and Prilocaine

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1468Lidocaine and PrilocaineLidocaine and PrilocaineImpax GenericsANDACurrent
0115-1468Lidocaine and PrilocaineLidocaine and PrilocaineAmneal Pharmaceuticals of New York LLCANDACurrent
50090-2167Lidocaine and PrilocaineLidocaine and PrilocaineA-S Medication SolutionsANDACurrent
68788-9320Lidocaine and PrilocaineLidocaine and PrilocainePreferred Pharmaceuticals, Inc.ANDACurrent