Home Applications 020769 Application 020769
Type NDA
Sponsor PRECISION DERMAT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOCOID LIPOCREAM HYDROCORTISONE BUTYRATE CREAM;TOPICAL 0.1% Yes 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 N020769-001 LOCOID LIPOCREAM HYDROCORTISONE BUTYRATE 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020769-001 AB2
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 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16781-384 Locoid Lipocream HYDROCORTISONE BUTYRATE Bausch Health US, LLC NDA Current 16781-384 Locoid Lipocream HYDROCORTISONE BUTYRATE Onset Dermatologics LLC NDA Current 16781-384 Locoid Lipocream HYDROCORTISONE BUTYRATE Bausch Health US, LLC NDA Current 16781-384 Locoid Lipocream HYDROCORTISONE BUTYRATE Bausch Health US, LLC NDA Current 68682-384 Hydrocortisone Butyrate HYDROCORTISONE BUTYRATE Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-384 Hydrocortisone Butyrate HYDROCORTISONE BUTYRATE Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-384 Hydrocortisone Butyrate HYDROCORTISONE BUTYRATE Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 79822 SUPPL 2024-10-07 79817 SUPPL 2024-10-04 13388 SUPPL 2014-12-19 25758 SUPPL 2014-11-24 25757 SUPPL 2009-10-26 35312 SUPPL 2009-10-21 3307 SUPPL 2006-04-24 3306 SUPPL 2004-08-25 41684 ORIG 2003-08-07