Home Applications 072192 Application 072192
Type ANDA
Sponsor OXFORD PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072192-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072192-001 AB
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 · 42 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 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0603-6160 Trazodone Hydrochloride Trazodone Hydrochloride Par Pharmaceutical ANDA Current 0603-6160 Trazodone Hydrochloride Trazodone Hydrochloride Par Pharmaceutical ANDA Current 12634-193 Trazodone Hydrochloride Trazodone Hydrochloride Apotheca Inc. ANDA Current 43353-652 Trazodone Hydrochloride Trazodone Hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current 45865-431 Trazodone Hydrochloride Trazodone Hydrochloride Medsource Pharmaceuticals ANDA Current 45865-431 Trazodone Hydrochloride Trazodone Hydrochloride Medsource Pharmaceuticals ANDA Current 55700-275 Trazodone Hydrochloride Trazodone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-275 Trazodone Hydrochloride Trazodone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 61919-386 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE DIRECT RX ANDA Current 63187-680 Trazodone Hydrochloride Trazodone Hydrochloride Proficient Rx LP ANDA Current 63187-680 Trazodone Hydrochloride Trazodone Hydrochloride Proficient Rx LP ANDA Current 63629-1513 Trazodone Hydrochloride Trazodone Hydrochloride Bryant Ranch Prepack ANDA Current 66267-392 Trazodone Hydrochloride Trazodone Hydrochloride NuCare Pharmaceuticals, Inc. ANDA Current 66267-392 Trazodone Hydrochloride Trazodone Hydrochloride NuCare Pharmaceuticals, Inc. ANDA Current 67046-739 Trazodone Hydrochloride Trazodone Hydrochloride Contract Pharmacy Services-PA ANDA Current 68387-165 Trazodone Hydrochloride Trazodone Hydrochloride Keltman Pharmaceuticals Inc. ANDA Current