Home Applications 210978 Application 210978
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOBAZAM CLOBAZAM SUSPENSION;ORAL 2.5MG/ML No No
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 A210978-001 CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210978-001 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 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL 2019-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210978-001 CLOBAZAM 2.5MG/ML SUSPENSION / ORAL AB 2019-04-15 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clobazam CLOBAZAM Sun Pharmaceutical Industries, Inc. fd1e63bf-496c-427c-83b7-6acabc00a5e5 2026-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210978 application number: ANDA210978 ndc (product): 51672-4227
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51672-4210 Clobazam clobazam Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4227 Clobazam clobazam Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-4227 Clobazam clobazam Taro Pharmaceuticals U.S.A., Inc. ANDA Current