Home Applications 017533 Application 017533
Type NDA
Sponsor ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KLONOPIN CLONAZEPAM TABLET;ORAL 0.5MG Yes No 002 KLONOPIN CLONAZEPAM TABLET;ORAL 1MG Yes Yes 003 KLONOPIN CLONAZEPAM TABLET;ORAL 2MG Yes No 005 KLONOPIN CLONAZEPAM TABLET;ORAL 0.125MG No No 006 KLONOPIN CLONAZEPAM TABLET;ORAL 0.25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017533-001 KLONOPIN CLONAZEPAM 0.5MG TABLET / ORAL AB RLD, Approved before 1982 N017533-002 KLONOPIN CLONAZEPAM 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 N017533-003 KLONOPIN CLONAZEPAM 2MG TABLET / ORAL AB RLD, Approved before 1982 N017533-005 KLONOPIN CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09 N017533-006 KLONOPIN CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-09
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 4 of 6 · 220 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 2021-03-12 10:30 UTC 2021-03 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N017533-001 KLONOPIN 0.5MG TABLET / ORAL AB RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017533-002 KLONOPIN 1MG TABLET / ORAL AB RLD, RS, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017533-003 KLONOPIN 2MG TABLET / ORAL AB RLD, Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017533-005 KLONOPIN 0.125MG TABLET / ORAL 1997-04-09 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N017533-006 KLONOPIN 0.25MG TABLET / ORAL 1997-04-09 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0058 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0068 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 0004-0098 Klonopin Clonazepam Genentech, Inc. NDA Current 61269-605 Klonopin Clonazepam H2-Pharma, LLC NDA Current 61269-605 Klonopin Clonazepam H2-Pharma, LLC NDA Current 61269-610 Klonopin Clonazepam H2-Pharma, LLC NDA Current 61269-610 Klonopin Clonazepam H2-Pharma, LLC NDA Current 61269-620 Klonopin Clonazepam H2-Pharma, LLC NDA Current 61269-620 Klonopin Clonazepam H2-Pharma, LLC NDA Current 65084-308 Klonopin Clonazepam Mckesson Rxpak Inc NDA Current 65084-309 Klonopin Clonazepam Mckesson Rxpak Inc NDA Current