Home Applications 074925 Application 074925
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLONAZEPAM CLONAZEPAM TABLET;ORAL 0.5MG No No 002 CLONAZEPAM CLONAZEPAM TABLET;ORAL 1MG No No 003 CLONAZEPAM CLONAZEPAM TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074925-001 CLONAZEPAM CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-09-30 A074925-002 CLONAZEPAM CLONAZEPAM 1MG TABLET / ORAL AB 1997-09-30 A074925-003 CLONAZEPAM CLONAZEPAM 2MG TABLET / ORAL AB 1997-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074925-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074925-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL AB 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074925-002 CLONAZEPAM 1MG TABLET / ORAL AB 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074925-003 CLONAZEPAM 2MG TABLET / ORAL AB 1997-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074925-002 CLONAZEPAM 1MG TABLET / ORAL 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074925-003 CLONAZEPAM 2MG TABLET / ORAL 1997-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074925-001 CLONAZEPAM 0.5MG TABLET / ORAL 1997-09-30 1e350fbaab3a…
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 Clonazepam CLONAZEPAM Chartwell RX, LLC 7b543f77-4388-4227-942f-7933f200b3a5 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074925 application number: ANDA074925
Documents# Document, Submission type, Date table Document Submission type Date 42898 ORIG 2011-03-10