Home Applications 204574 Application 204574
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TETRABENAZINE TETRABENAZINE TABLET;ORAL 12.5MG No No 002 TETRABENAZINE TETRABENAZINE TABLET;ORAL 25MG No No
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 A204574-001 TETRABENAZINE TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 A204574-002 TETRABENAZINE TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204574-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2016-02-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204574-002 TETRABENAZINE 25MG TABLET / ORAL AB 2016-02-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 31722-821 Tetrabenazine Tetrabenazine Camber Pharmaceuticals, Inc. ANDA Current 31722-822 Tetrabenazine Tetrabenazine Camber Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10358 ORIG 2016-02-05