Home Applications 021902 Application 021902
Type NDA
Sponsor FOUGERA PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VEREGEN SINECATECHINS OINTMENT;TOPICAL 15% Yes Yes
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 N021902-001 VEREGEN SINECATECHINS 15% OINTMENT / TOPICAL RLD, RS 2006-10-31
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03
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 · 43 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 2026-09-14 22:38:34 2026-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021902-001 VEREGEN 15% OINTMENT / TOPICAL RLD, RS 2006-10-31 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 104 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 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021902-001 9770406 2025-07-12 U-172 Drug product 2017-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021902-001 7858662 2026-10-02 U-172 Drug product 2011-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021902-001 5795911 2020-10-31 U-172 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021902-001 10434059 2022-11-18 U-172 Drug product 2019-10-16 74a2ff9319b5…
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.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10337-450 Veregen sinecatechins PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 10337-450 Veregen sinecatechins PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 10337-450 Veregen sinecatechins PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 10337-450 Veregen sinecatechins PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 62559-385 Veregen sinecatechins ANI Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 56947 SUPPL 2018-12-21 56898 SUPPL 2018-12-20 6416 SUPPL 2013-03-04 37845 SUPPL 2012-11-26 6415 SUPPL 2012-11-21 6414 SUPPL 2008-09-23 16542 SUPPL 2008-09-19 6413 SUPPL 2008-01-09 16541 SUPPL 2007-12-27 28808 SUPPL 2007-06-07 16540 SUPPL 2007-06-04 42342 ORIG 2007-01-08 28807 ORIG 2006-11-06 16539 ORIG 2006-11-06