FDA.reportPublic FDA data

Application 209190

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEPATCH;TOPICAL5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209190-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2020-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209190-001AB

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
2026-08-01 22:54:322026-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209190-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 5%LIDOCAINE 5%St. Mary's Medical Park Pharmacy052fa8a3-0e3c-d9c2-e063-6394a90aadd72026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidox 5 PatchLIDOCAINE 5% PATCHInjecta Medcial LLC526b8681-098f-3410-e063-6294a90a79fb2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%YARAL Pharma Inc.fc495fc8-15d6-27c7-e053-6394a90ab30d2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
LidocanLIDOCAINE 5%PURETEK CORPORATIONfd8e4856-3785-4850-e053-6294a90a95b62026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%A-S Medication Solutionsfec1e759-60e4-47d4-bd54-947f18b103dd2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5% PatchLIDOCAINE 5%Medcore LLC1afe428f-e223-4ef8-a6ba-968f4cfbf4762026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine IIILIDOCAINETrifluent Pharma LLC9b47102e-3b35-4aa7-a380-cd02ba9eac652025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine XLLIDOCAINETrifluent Pharma LLC032b37a7-8a47-4809-a330-c76314225cbd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%REMEDYREPACK INC.50152ae0-aebd-4a08-a5c7-c8858e0259972025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%Asclemed USA, Inc.1dca5b81-72a9-4969-8552-d43091f72aab2025-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VILIDOCAINE 5%PURETEK CORPORATION1b6dc518-a15b-1cf9-e063-6294a90a63572024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VIILIDOCAINE 5%PURETEK CORPORATION1f33d51c-168c-55f2-e063-6394a90a89052024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IVLIDOCAINE 5%PURETEK CORPORATION137f9cc1-68c0-edcc-e063-6394a90abf6a2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VLIDOCAINE 5%PURETEK CORPORATION141fe2bd-b25a-eff8-e063-6294a90a2ae82024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IIILIDOCAINE 5%PURETEK CORPORATION07a258e4-4858-43b3-e063-6394a90a50842024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%NuCare Pharmaceuticals,Inc.1ac8a196-010f-a986-e063-6294a90a948f2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-118Lidocaine 5%Lidocaine 5%Rhodes Pharmaceuticals L.P.ANDACurrent
63629-2472Lidocaine 5%Lidocaine 5%Bryant Ranch PrepackANDACurrent
63629-2472Lidocaine 5%Lidocaine 5%Bryant Ranch PrepackANDACurrent
70518-3522Lidocaine 5%Lidocaine 5%REMEDYREPACK INC.ANDACurrent
80175-0118Lidocaine 5%LidocaineCentral PackagingANDACurrent
80175-0118Lidocaine 5%LidocaineCentral PackagingANDACurrent
80175-0118Lidocaine 5%LidocaineCentral PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77884ORIG 2024-08-06