Home Applications 020648 Application 020648
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIASTAT DIAZEPAM GEL;RECTAL 2.5MG/0.5ML (5MG/ML) Yes No 002 DIASTAT DIAZEPAM GEL;RECTAL 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 DIASTAT DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 DIASTAT DIAZEPAM GEL;RECTAL 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 005 DIASTAT DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 006 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) Yes Yes 007 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020648-001 DIASTAT DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 N020648-002 DIASTAT DIAZEPAM 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-003 DIASTAT DIAZEPAM 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-004 DIASTAT DIAZEPAM 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-005 DIASTAT DIAZEPAM 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-006 DIASTAT ACUDIAL DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 N020648-007 DIASTAT ACUDIAL DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15
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 8 · 301 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 2026-09-14 22:38:34 2026-08 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 53 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 · 42 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-6137 Diazepam Diazepam Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6138 Diazepam Diazepam Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6138 Diazepam Diazepam Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6139 Diazepam Diazepam Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0093-6139 Diazepam Diazepam Teva Pharmaceuticals USA, Inc. NDA AUTHORIZED GENERIC Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US LLC NDA Current 0187-0658 Diastat diazepam Bausch Health Americas, Inc. NDA Current 0187-0658 Diastat diazepam Valeant Pharmaceuticals North America LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0658 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US LLC NDA Current 0187-0659 Diastat diazepam Bausch Health Americas, Inc. NDA Current 0187-0659 Diastat diazepam Valeant Pharmaceuticals North America LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 0187-0659 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 66490-650 Diastat diazepam Valeant Pharmaceuticals North America LLC NDA Current 66490-650 Diastat diazepam Bausch Health US, LLC NDA Current 68682-650 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-650 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-650 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-650 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-652 Diazepam diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-652 Diazepam diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-652 Diazepam diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-652 Diazepam diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-655 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-655 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-655 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-655 Diazepam Diazepam Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current