Home Applications 205098 Application 205098
Type NDA
Sponsor PROVENSIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VARITHENA POLIDOCANOL SOLUTION;INTRAVENOUS 180MG/18ML (10MG/ML) Yes Yes 002 VARITHENA POLIDOCANOL SOLUTION;INTRAVENOUS 77.5MG/7.75ML (10MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205098-001 VARITHENA POLIDOCANOL 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 N205098-002 VARITHENA POLIDOCANOL 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205098-001 7814943 2027-11-19 U-1461 Drug product N205098-001 9480652 2032-05-12 Drug product 2016-11-30
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 3 · 84 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 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 6 · 226 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205098-001 7814943 2027-11-19 U-1461 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205098-001 7814943 2027-11-19 U-1461 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 7814943 2027-11-19 U-1461 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205098-001 7814943 2027-11-19 U-1461 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 7814943 2027-11-19 U-1461 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 7814943 2027-11-19 U-1461 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 8122917 2024-09-09 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 7814943 2027-11-19 U-1461 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 8122917 2024-09-09 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 7814943 2027-11-19 U-1461 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 8122917 2024-09-09 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 7814943 2027-11-19 U-1461 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 8122917 2024-09-09 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 7814943 2027-11-19 U-1461 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205098-001 8122917 2024-09-09 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 7814943 2027-11-19 U-1461 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 8122917 2024-09-09 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 7814943 2027-11-19 U-1461 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 8122917 2024-09-09 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 7814943 2027-11-19 U-1461 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 301d65b070ca…
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 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60635-107 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-107 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-107 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-107 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-111 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-111 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-111 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-111 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-118 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-118 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-118 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-118 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-118 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-123 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-133 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-133 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-133 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-133 Varithena polidocanol Biocompatibles, Inc. NDA Current 60635-133 Varithena polidocanol Biocompatibles, Inc. NDA Current