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 1 .
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.
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 2026-08-01 22:54:32 2026-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 a50c72e98297…
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 2026-08-01 22:54:32 2026-06 N205098-001 7814943 2027-11-19 U-1461 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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