Home Applications 203601 Application 203601
Type ANDA
Sponsor AVANTHI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE TABLET;ORAL 5MG No No 002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE TABLET;ORAL 10MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203601-001 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 A203601-002 OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 of 3 · 88 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 2019-12-13 00:20 UTC 2019-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203601-001 OXYMORPHONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-01-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203601-002 OXYMORPHONE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2013-01-30 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10702-070 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-070 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-070 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-070 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-071 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-071 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-071 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 10702-071 Oxymorphone Hydrochloride Oxymorphone Hydrochloride KVK-Tech, Inc. ANDA Current 35356-967 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-967 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-967 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-968 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-968 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-968 Oxymorphone Hydrochloride Oxymorphone Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76336 ORIG 2023-11-03