Home Applications 091498 Application 091498
Type ANDA
Sponsor CSPC OUYI PHARM CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091498-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091498-001 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 · 41 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 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 45865-357 Tramadol Hydrochloride Tramadol Hydrochloride Medsource Pharmaceuticals ANDA Current 50090-4716 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE A-S Medication Solutions ANDA Current 50090-4717 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE A-S Medication Solutions ANDA Current 50436-0136 TRAMADOL HYDROCHLORIDE Tramadol Hydrochloride Unit Dose Services ANDA Current 53002-4321 Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE RPK Pharmaceuticals, Inc. ANDA Current 53002-4321 Tramadol Hydrochloride Tramadol Hydrochloride RPK Pharmaceuticals, Inc. ANDA Current 55700-412 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-412 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 61786-487 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride REMEDYREPACK INC. ANDA Current 67046-887 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Contract Pharmacy Services-PA ANDA Current 67296-1329 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE RedPharm Drug, Inc. ANDA Current 68071-4154 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 68071-4154 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 68071-4154 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 69543-136 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Virtus Pharmaceuticals LLC ANDA Current 69543-136 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Virtus Pharmaceuticals LLC ANDA Current 69543-136 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Virtus Pharmaceuticals LLC ANDA Current 69543-136 Tramadol Hydrochloride Tramadol Hydrochloride Virtus Pharmaceuticals LLC ANDA Current 71205-389 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Proficient Rx LP ANDA Current 71205-389 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Proficient Rx LP ANDA Current 71205-389 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Proficient Rx LP ANDA Current 71205-389 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Proficient Rx LP ANDA Current 71335-1498 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Bryant Ranch Prepack ANDA Current 71610-398 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC ANDA Current 76420-127 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE Asclemed USA, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76320 ORIG 2023-11-03