Application 211499

Type: ANDA
Sponsor: ABHAI LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	325MG/5ML;5MG/5ML	No	Yes

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
A211499-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31

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 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	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL		RS	2018-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211499-001	OXYCODONE AND ACETAMINOPHEN	325MG/5ML;5MG/5ML	SOLUTION / ORAL	AA	RS	2018-12-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A211499-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211499-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211499-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211499-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211499-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211499-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211499-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211499-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211499-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211499-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211499-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211499-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211499-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211499-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211499-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211499-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211499-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211499-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211499-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211499-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211499-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211499-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211499-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211499-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211499-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211499-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211499-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211499-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211499-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211499-001	AA	1	`cb3db0bc1861…`

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
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	KVK-Tech, Inc.	9986aa04-c976-4654-8ad7-b97d2eecea93	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211499 application number: ANDA211499 ndc (product): 10702-238

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-238	OXYCODONE AND ACETAMINOPHEN	oxycodone and acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-238	OXYCODONE AND ACETAMINOPHEN	oxycodone and acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-238	OXYCODONE AND ACETAMINOPHEN	oxycodone and acetaminophen	KVK-Tech, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76433	ORIG	2023-11-07