FDA.reportPublic FDA data

Application 076090

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERMETHRINPERMETHRINLOTION;TOPICAL1%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
A076090-001PERMETHRINPERMETHRIN1%LOTION / TOPICAL2001-12-20

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 UTC2022-10A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076090-001PERMETHRIN1%LOTION / TOPICAL2001-12-20a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense lice killing creme rinsePERMETHRINL. Perrigo Company056fb377-34dd-4d33-83d7-c895b105f5742022-11-21WarningsExact identifier
application applno (ANDA): 076090
application number: ANDA076090
ndc (product): 0113-1910
Topcare lice killing creme rinsePERMETHRINTopco Associates LLC3b4146a6-7c54-4dd0-9388-1e38491d16f32020-01-31WarningsExact identifier
application applno (ANDA): 076090
application number: ANDA076090
ndc (product): 36800-629

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-1910good sense lice killing creme rinsePermethrinL. Perrigo CompanyANDACurrent
0113-1910good sense lice killing creme rinsePermethrinL. Perrigo CompanyANDACurrent
0363-0955lice treatmentPermethrinWalgreen CompanyANDACurrent
0363-0955lice treatmentPermethrinWalgreen CompanyANDACurrent
0363-0955lice treatmentPermethrinWalgreen CompanyANDACurrent
11822-0549lice treatmentPermethrinRite Aid CorporationANDACurrent
36800-629Topcare lice killing creme rinsePermethrinTopco Associates LLCANDACurrent
36800-955topcare lice treatmentPermethrinTopco Associates LLCANDACurrent
42507-955lice treatmentPermethrinHyVee IncANDACurrent
46122-108good neighbor pharmacy lice treatmentPermethrinAmerisource BergenANDACurrent
49348-150sunmark lice treatmentPermethrinStrategic Sourcing Services LLCANDACurrent
49348-150sunmark lice treatmentPermethrinStrategic Sourcing Services LLCANDACurrent
49348-150sunmark lice treatmentPermethrinMckessonANDACurrent
49781-028leader lice treatmentPermethrinCardinal HealthANDACurrent
49781-028leader lice treatmentPermethrinCardinal HealthANDACurrent
50090-3478sunmark lice treatmentPermethrinA-S Medication SolutionsANDACurrent
59779-769Lice TreatmentPermethrinCVS PharmacyANDACurrent
62011-0255health mart lice treatmentPermethrinMcKessonANDACurrent
62011-0255health mart lice treatmentPermethrinStrategic Sourcing Services LLCANDACurrent
62011-0255health mart lice treatmentPermethrinStrategic Sourcing Services LLCANDACurrent
70000-0041leader lice treatmentPermethrinCardinal HealthANDACurrent
70000-0041leader lice treatmentPermethrinCardinal HealthANDACurrent
70000-0041leader lice treatmentPermethrinCardinal Health 110, LLC. dba LeaderANDACurrent
76413-320PermethrinPermethrinCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22534ORIG2005-07-22