Home Applications 021201 Application 021201
Type NDA
Sponsor CHEMISCH FBRK KRSSLR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASCLERA POLIDOCANOL SOLUTION;INTRAVENOUS 10MG/2ML (5MG/ML) Yes No 002 ASCLERA POLIDOCANOL SOLUTION;INTRAVENOUS 20MG/2ML (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 N021201-001 ASCLERA POLIDOCANOL 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 N021201-002 ASCLERA POLIDOCANOL 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30
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 · 82 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 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021201-001 ASCLERA 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2010-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021201-002 ASCLERA 20MG/2ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-03-30 782e0a99824c…
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 46783-121 Asclera POLIDOCANOL Merz North America, Inc NDA Current 46783-121 Asclera POLIDOCANOL Merz North America, Inc NDA Current 46783-121 Asclera POLIDOCANOL Merz North America, Inc NDA Current 46783-221 Asclera POLIDOCANOL Merz North America, Inc NDA Current 46783-221 Asclera POLIDOCANOL Merz North America, Inc NDA Current 46783-221 Asclera POLIDOCANOL Merz North America, Inc NDA Current 67850-140 Asclera POLIDOCANOL Methapharm, Inc NDA Current 67850-141 Asclera POLIDOCANOL Methapharm, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81905 SUPPL 2025-04-09 81883 SUPPL 2025-04-08 60211 SUPPL 2019-10-03 59894 SUPPL 2019-09-03 52789 SUPPL 2018-03-02 52773 SUPPL 2018-03-01 42017 ORIG 2010-04-22 24187 ORIG 2010-04-22 27050 ORIG 2010-04-09 36335 ORIG 2010-04-04