Home Applications 020576 Application 020576
Type NDA
Sponsor ORPHAN EUROPE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYSTADANE BETAINE FOR SOLUTION;ORAL 1GM/SCOOPFUL 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 N020576-001 CYSTADANE BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020576-001 AB
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 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 1996-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020576-001 CYSTADANE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB RLD, RS 1996-10-25 cb3db0bc1861…
Observed Orange Book normalized TE 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.
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 52276-400 Cystadane betaine Recordati Rare Diseases NDA Current 52276-400 Cystadane betaine Orphan Europe SARL NDA Current 52276-400 Cystadane betaine Recordati Rare Diseases NDA Current 64811-400 Cystadane BETAINE Ropack Inc. NDA Current 66621-4000 Cystadane betaine Rare Disease Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57666 ORIG 2019-02-15 56449 SUPPL 2018-11-15 56366 SUPPL 2018-11-08 2765 SUPPL 2010-04-08 12759 SUPPL 2010-04-05 2764 SUPPL 2006-03-01 34873 SUPPL 2006-02-28