Home Applications 077749 Application 077749
Type ANDA
Sponsor VINTAGE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIAZEPAM DIAZEPAM TABLET;ORAL 2MG No No 002 DIAZEPAM DIAZEPAM TABLET;ORAL 5MG No No 003 DIAZEPAM DIAZEPAM TABLET;ORAL 10MG 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 A077749-001 DIAZEPAM DIAZEPAM 2MG TABLET / ORAL 2006-03-31 A077749-002 DIAZEPAM DIAZEPAM 5MG TABLET / ORAL 2006-03-31 A077749-003 DIAZEPAM DIAZEPAM 10MG TABLET / ORAL 2006-03-31
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 · 123 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 A077749-001 DIAZEPAM 2MG TABLET / ORAL 2006-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077749-002 DIAZEPAM 5MG TABLET / ORAL 2006-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077749-003 DIAZEPAM 10MG TABLET / ORAL 2006-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077749-002 DIAZEPAM 5MG TABLET / ORAL AB 2006-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077749-003 DIAZEPAM 10MG TABLET / ORAL AB 2006-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077749-001 DIAZEPAM 2MG TABLET / ORAL AB 2006-03-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0603-3215 Diazepam diazepam Qualitest Pharmaceuticals ANDA Current 10544-161 Diazepam diazepam Blenheim Pharmacal, Inc. ANDA Current 33261-034 Diazepam diazepam Aidarex Pharmaceuticals LLC ANDA Current 33261-035 Diazepam diazepam Aidarex Pharmaceuticals LLC ANDA Current 33261-717 Diazepam diazepam Aidarex Pharmaceuticals LLC ANDA Current 43353-783 Diazepam diazepam Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-820 Diazepam diazepam Aphena Pharma Solutions - Tennessee, LLC ANDA Current 50090-0193 Diazepam diazepam A-S Medication Solutions ANDA Current 50090-0194 Diazepam diazepam A-S Medication Solutions ANDA Current 50436-3593 Diazepam diazepam Unit Dose Services ANDA Current 61919-071 DIAZEPAM DIAZEPAM DIRECT RX ANDA Current 61919-377 DIAZEPAM DIAZEPAM DIRECT RX ANDA Current 61919-906 DIAZEPAM DIAZEPAM Direct_Rx ANDA Current 61919-906 DIAZEPAM DIAZEPAM Direct_Rx ANDA Current 61919-906 DIAZEPAM DIAZEPAM Direct_Rx ANDA Current 61919-906 DIAZEPAM DIAZEPAM Direct_Rx ANDA Current 61919-906 DIAZEPAM DIAZEPAM Direct_Rx ANDA Current 63187-309 Diazepam diazepam Proficient Rx LP ANDA Current 66267-068 Diazepam diazepam NuCare Pharmaceuticals, Inc. ANDA Current 66267-068 Diazepam diazepam NuCare Pharmaceuticals, Inc. ANDA Current 66336-033 Diazepam diazepam Dispensing Solutions, Inc. ANDA Current 66336-478 Diazepam diazepam Dispensing Solutions, Inc. ANDA Current 67544-720 Diazepam diazepam Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68788-9936 Diazepam diazepam Preferred Pharmaceuticals, Inc. ANDA Current 68788-9937 Diazepam diazepam Preferred Pharmaceuticals, Inc. ANDA Current