Home Applications 089996 Application 089996
Type ANDA
Sponsor PERRIGO NEW YORK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SELENIUM SULFIDE SELENIUM SULFIDE LOTION/SHAMPOO;TOPICAL 2.5% No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089996-001 SELENIUM SULFIDE SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10
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 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL AT RS 1991-01-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089996-001 SELENIUM SULFIDE 2.5% LOTION/SHAMPOO / TOPICAL RS 1991-01-10 e64feba35796…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45802-040 SELENIUM SULFIDE SELENIUM SULFIDE Perrigo New York Inc ANDA Current 45802-040 SELENIUM SULFIDE SELENIUM SULFIDE Padagis Israel Pharmaceuticals Ltd ANDA Current 50090-0242 SELENIUM SULFIDE SELENIUM SULFIDE A-S Medication Solutions ANDA Current 53002-8260 SELENIUM SULFIDE SELENIUM SULFIDE RPK Pharmaceuticals, Inc. ANDA Current 53002-8260 SELENIUM SULFIDE SELENIUM SULFIDE RPK Pharmaceuticals, Inc. ANDA Current 68071-1768 SELENIUM SULFIDE SELENIUM SULFIDE NuCare Pharmaceuticals,Inc. ANDA Current