Home Applications 202317 Application 202317
Type NDA
Sponsor HELSINN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALCHLOR MECHLORETHAMINE HYDROCHLORIDE GEL;TOPICAL EQ 0.016% BASE 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 N202317-001 VALCHLOR MECHLORETHAMINE HYDROCHLORIDE EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202317-001 7838564 2026-03-07 Drug product 2013-09-13 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 N202317-001 7872050 2029-07-08 U-1427 2013-09-13
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.
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 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202317-001 VALCHLOR EQ 0.016% BASE GEL / TOPICAL RLD, RS 2013-08-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 9382191 2026-03-07 Drug product 2016-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202317-001 7872050 2029-07-08 U-1427 2013-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 7838564 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8450375 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8501818 2026-03-07 Drug product 2013-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202317-001 8501819 2026-03-07 U-1427 2013-09-13 2680178bc6a6…
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 VALCHLOR MECHLORETHAMINE HYDROCHLORIDE Helsinn Therapeutics (U.S.), Inc. 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57 2024-11-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 202317 application number: NDA202317 ndc (product): 69639-120
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66215-001 Non-medicated VALCHLOR Demonstration Non-medicated VALCHLOR Demonstration Actelion Pharmaceuticals US, Inc. NDA Current 66215-016 VALCHLOR mechlorethamine hydrochloride Actelion Pharmaceuticals US, Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current 69639-120 VALCHLOR mechlorethamine hydrochloride Helsinn Therapeutics (U.S.), Inc. NDA Current