Home Applications 021852 Application 021852
Type NDA
Sponsor LEO PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE OINTMENT;TOPICAL 0.064%;0.005% 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 N021852-001 TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021852-001 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 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 N021852-001 6753013 2020-01-27 U-193 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021852-001 6753013 2020-01-27 U-88 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021852-001 6753013 2020-01-27 U-193 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021852-001 6753013 2020-01-27 U-88 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021852-001 6753013 2020-01-27 U-193 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021852-001 6753013 2020-01-27 U-88 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021852-001 6753013 2020-01-27 U-193 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021852-001 6753013 2020-01-27 U-88 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021852-001 6753013 2020-01-27 U-193 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021852-001 6753013 2020-01-27 U-88 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021852-001 6753013 2020-01-27 U-88 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021852-001 6753013 2020-01-27 U-193 Drug product 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45802-989 Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate Perrigo New York Inc NDA AUTHORIZED Current 45802-989 Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate Perrigo New York Inc NDA AUTHORIZED GENERIC Current 45802-989 Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate Perrigo New York Inc NDA AUTHORIZED GENERIC Current 45802-989 Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate Perrigo New York Inc NDA AUTHORIZED GENERIC Current 50222-227 Taclonex calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-227 Taclonex calcipotriene and betamethasone dipropionate LEO Pharma Inc NDA Current 50222-227 Taclonex calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-227 Taclonex calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-227 Taclonex calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 66993-938 Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-938 Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-938 Calcipotriene and Betamethasone Dipropionate Calcipotriene and Betamethasone Dipropionate Prasco Laboratories NDA AUTHORIZED GENERIC Current