Home Applications 213422 Application 213422
Type NDA
Sponsor MC2 Therapeutics Ltd Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WYNZORA CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE CREAM;TOPICAL 0.005%/0.064% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N213422-001 WYNZORA BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213422-001 10265265 2027-09-27 Drug product 2020-08-27 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13
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.
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 2026-09-14 22:38:34 2026-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 67 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 bb7c543d1eb4…
Observed Orange Book exclusivity 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Wynzora CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE MC2 Therapeutics Ltd 36c5c818-0d40-445e-a3c0-0f46723a25e2 2023-11-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 213422 application number: NDA213422 ndc (product): 73499-001
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73499-001 Wynzora Calcipotriene and Betamethasone dipropionate MC2 Therapeutics Ltd NDA Current 73499-001 Wynzora Calcipotriene and Betamethasone dipropionate MC2 Therapeutics Ltd NDA Current 73499-001 Wynzora Calcipotriene and Betamethasone dipropionate MC2 Therapeutics Inc NDA Current 73499-001 Wynzora Calcipotriene and Betamethasone dipropionate MC2 Therapeutics Ltd NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69427 ORIG 2021-12-01 65227 ORIG 2020-11-16 64005 ORIG 2020-07-22 63978 ORIG 2020-07-21