Home Applications 202736 Application 202736
Type NDA
Sponsor ARBOR PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SKLICE IVERMECTIN LOTION;TOPICAL 0.5% Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202736-001 SKLICE IVERMECTIN 0.5% LOTION / TOPICAL RLD, RS 2012-02-07
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL AB RLD, RS 2012-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202736-001 SKLICE 0.5% LOTION / TOPICAL RLD, RS 2012-02-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 N202736-001 AB 1 c0c555d07b60…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 74a2ff9319b5…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202736-001 8791153 2027-10-12 Drug product, Delist requested 2014-08-27 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202736-001 8927595 2027-10-12 U-1782 Delist requested 2015-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202736-001 8791153 2027-10-12 Drug product 2014-08-27 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202736-001 8927595 2027-10-12 U-1782 2015-12-17 ea99ee380514…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24338-183 Sklice IVERMECTIN Arbor Pharmaceuticals NDA Current 24338-185 Sklice ivermectin Azurity Pharmaceuticals NDA Current 24338-185 Sklice ivermectin Arbor Pharmaceuticals NDA Current