FDA.reportPublic FDA data

Application 075014

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERMETHRINPERMETHRINLOTION;TOPICAL1%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
A075014-001PERMETHRINPERMETHRIN1%LOTION / TOPICAL2000-03-28

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PermethrinPERMETHRIN CREAM 5% W/WPreferred Pharmaceuticals Inc.d0d6b1ac-2f3a-433b-ba2b-832be3e0f93f2026-08-13Warnings, Adverse reactionsName fallback
brand name: Permethrin
PermethrinPERMETHRINDr. Reddy's Laboratories, Inc.31de941a-d5b9-8de5-6695-daca8b57d0102026-07-24Warnings, Adverse reactionsName fallback
brand name: Permethrin
generic name: PERMETHRIN
PERMETHRINPERMETHRINAurobindo Pharma Limited0c92aca1-0daa-4b24-9348-f9d42fec478a2026-03-04Warnings, Adverse reactionsName fallback
brand name: PERMETHRIN
generic name: PERMETHRIN
PermethrinPERMETHRIN CREAM 5% W/WREMEDYREPACK INC.e3d77092-dad6-4df5-ac39-ff9dc8f5758c2026-02-13Warnings, Adverse reactionsName fallback
brand name: Permethrin
PermethrinPERMETHRINBryant Ranch Prepack850414a5-a261-40ac-999e-cdcbd23c0cb02025-10-24Warnings, Adverse reactionsName fallback
brand name: Permethrin
generic name: PERMETHRIN
Nix Complete Lice TreatmentPERMETHRINInsight Pharmaceuticals LLCcca42777-01bf-4352-acdb-441160d695572025-10-23WarningsName fallback
generic name: PERMETHRIN
NixPERMETHRINInsight Pharmaceuticals LLCd6dfa64a-bb88-4438-b4e2-30c6fbb28f3e2025-10-23WarningsName fallback
generic name: PERMETHRIN
PermethrinPERMETHRIN CREAM 5% W/WEncube Ethicals, Inc.35225d0a-3bde-4c7d-bdf9-81661012e77c2025-10-09Warnings, Adverse reactionsName fallback
brand name: Permethrin
PermethrinPERMETHRINBryant Ranch Prepackf4af5093-2e4a-43c6-b585-4bb14f73f3702025-09-25Warnings, Adverse reactionsName fallback
brand name: Permethrin
generic name: PERMETHRIN
PermethrinPERMETHRINNorthstar Rx LLC11e91140-cf12-42de-9f4a-cdbc22e746582025-05-16Warnings, Adverse reactionsName fallback
brand name: Permethrin
generic name: PERMETHRIN
ELIMITEPERMETHRINAurobindo Pharma Limited443c0446-ccba-4f52-83ed-4c3163f358072024-01-24Warnings, Adverse reactionsName fallback
generic name: PERMETHRIN
PermethrinPERMETHRIN 5% W/WA-S Medication Solutions694abbf9-9460-4c55-b8c7-66220cabb5b62023-11-24Warnings, Adverse reactionsName fallback
brand name: Permethrin
PermethrinPERMETHRINPadagis Israel Pharmaceuticals Ltdbdb796aa-a7d1-4476-988f-2b4a9519788f2023-01-31Warnings, Adverse reactionsName fallback
brand name: Permethrin
generic name: PERMETHRIN
good sense lice killing creme rinsePERMETHRINL. Perrigo Company056fb377-34dd-4d33-83d7-c895b105f5742022-11-21WarningsName fallback
generic name: PERMETHRIN
Nix Lice Killing Creme RinsePERMETHRINGeodis Logistics LLCcf7c2429-9ae0-4435-b695-aafd5f207d272022-02-07WarningsName fallback
generic name: PERMETHRIN
Topcare lice killing creme rinsePERMETHRINTopco Associates LLC3b4146a6-7c54-4dd0-9388-1e38491d16f32020-01-31WarningsName fallback
generic name: PERMETHRIN

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-065Lice TreatmentpermethrinRebel Distributors CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18380ORIG2004-06-14
42920ORIG2003-08-04
8490ORIG2000-03-28