FDA.reportPublic FDA data

Application 089996

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELENIUM SULFIDESELENIUM SULFIDELOTION/SHAMPOO;TOPICAL2.5%NoYes

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
A089996-001SELENIUM SULFIDESELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10

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 UTC2022-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089996-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089996-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089996-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089996-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089996-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089996-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089996-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A089996-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089996-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089996-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089996-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A089996-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089996-001AT1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SELENIUM SULFIDESELENIUM SULFIDEPadagis Israel Pharmaceuticals Ltd28b84e3c-ae44-40bb-93c4-2625e19f7e612025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089996
application number: ANDA089996
ndc (product): 45802-040

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-040SELENIUM SULFIDESELENIUM SULFIDEPerrigo New York IncANDACurrent
45802-040SELENIUM SULFIDESELENIUM SULFIDEPadagis Israel Pharmaceuticals LtdANDACurrent
50090-0242SELENIUM SULFIDESELENIUM SULFIDEA-S Medication SolutionsANDACurrent
53002-8260SELENIUM SULFIDESELENIUM SULFIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-8260SELENIUM SULFIDESELENIUM SULFIDERPK Pharmaceuticals, Inc.ANDACurrent
68071-1768SELENIUM SULFIDESELENIUM SULFIDENuCare Pharmaceuticals,Inc.ANDACurrent