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 42.

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.

Application-product, TE code table
Application-product	TE code
A203601-001	AB
A203601-002	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 3 · 84 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	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203601-001	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203601-002	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2013-01-30	`4b0b4de00fa7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203601-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203601-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203601-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203601-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203601-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203601-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203601-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203601-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203601-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203601-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203601-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203601-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203601-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203601-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203601-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203601-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203601-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203601-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203601-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203601-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203601-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203601-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203601-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203601-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203601-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203601-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203601-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203601-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203601-002	AB	1	`bb7c543d1eb4…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	KVK-Tech, Inc.	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203601 application number: ANDA203601 ndc (product): 10702-071 ndc (product): 10702-070

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