Home Applications 070464 Application 070464
Type ANDA
Sponsor NUVO PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIAZEPAM DIAZEPAM TABLET;ORAL 10MG No No 002 DIAZEPAM DIAZEPAM TABLET;ORAL 2MG No No 003 DIAZEPAM DIAZEPAM TABLET;ORAL 5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A070464-001 DIAZEPAM DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 A070464-002 DIAZEPAM DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 A070464-003 DIAZEPAM DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10
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 2 · 63 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 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070464-002 DIAZEPAM 2MG TABLET / ORAL AB 2024-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070464-003 DIAZEPAM 5MG TABLET / ORAL AB 2024-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070464-001 DIAZEPAM 10MG TABLET / ORAL AB 1986-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070464-001 DIAZEPAM 10MG TABLET / ORAL 1986-02-25 782e0a99824c…
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 DIAZEPAM DIAZEPAM Sunrise Pharmaceutical, Inc. 34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8 2024-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070464 application number: ANDA070464