Home Applications 021470 Application 021470
Type NDA
Sponsor LEO PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FINACEA AZELAIC ACID GEL;TOPICAL 15% 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 N021470-001 FINACEA AZELAIC ACID 15% GEL / TOPICAL AB RLD, RS 2002-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021470-001 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 · 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 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 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 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc. NDA AUTHORIZED GENERIC Current 0781-7172 Azelaic Acid Gel azelaic acid Sandoz Inc NDA AUTHORIZED GENERIC Current 10922-825 Finacea azelaic acid Intendis Inc. NDA Current 10922-826 Finacea azelaic acid Intendis Inc. NDA Current 50090-3032 Finacea azelaic acid A-S Medication Solutions NDA Current 50090-3032 Finacea azelaic acid A-S Medication Solutions NDA Current 50090-4473 Finacea azelaic acid A-S Medication Solutions NDA Current 50090-4473 Finacea azelaic acid A-S Medication Solutions NDA Current 50090-4473 Finacea azelaic acid A-S Medication Solutions NDA Current 50090-4473 Finacea azelaic acid A-S Medication Solutions NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50222-505 Finacea azelaic acid LEO Pharma Inc. NDA Current 50419-825 Finacea azelaic acid Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-825 Finacea azelaic acid Bayer HealthCare Pharmaceuticals Inc. NDA Current