Home Applications 214864 Application 214864
Type ANDA
Sponsor NOVITIUM PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETAINE BETAINE FOR SOLUTION;ORAL 1GM/SCOOPFUL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A214864-001 BETAINE BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214864-001 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.
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 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214864-001 BETAINE 1GM/SCOOPFUL FOR SOLUTION / ORAL AB 2021-11-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0352 Betaine Betaine Cosette Pharmaceuticals, Inc. ANDA Current 70954-331 Betaine Anhydrous Betaine Anhydrous Novitium Pharma LLC ANDA Current 72647-900 Betaine Anhydrous for Oral Solution Betaine Anhydrous OAKRUM PHARMA, LLC ANDA Current 72647-900 Betaine Anhydrous for Oral Solution Betaine Anhydrous OAKRUM PHARMA, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69692 ORIG 2021-12-20