Home Applications 021644 Application 021644
Type NDA
Sponsor GALDERMA LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOBEX CLOBETASOL PROPIONATE SHAMPOO;TOPICAL 0.05% 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 N021644-001 CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021644-001 AB
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 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent 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 0299-3847 Clobex clobetasol propionate Galderma Laboratories, L.P. NDA Current 0299-3847 Clobex clobetasol propionate Galderma Laboratories, L.P. NDA Current 0781-7137 clobetasol propionate clobetasol propionate Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7137 clobetasol propionate clobetasol propionate Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7137 clobetasol propionate clobetasol propionate Sandoz Inc. NDA AUTHORIZED GENERIC Current 66993-939 clobetasol propionate clobetasol propionate Prasco Laboratories NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 15917 SUPPL 2014-01-14 5905 SUPPL 2012-12-03 37390 SUPPL 2012-08-20 28305 SUPPL 2012-08-20 42249 ORIG 2004-12-07 15916 ORIG 2004-03-03 28304 ORIG 2004-02-27