Application 210644

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	TABLET;ORAL	325MG;2.5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;5MG	No	No
003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210644-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09
A210644-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2018-02-09
A210644-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09
A210644-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2018-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A210644-001	AA
A210644-002	AA
A210644-003	AA
A210644-004	AA

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210644-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2018-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210644-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210644-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210644-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-02-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A210644-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210644-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210644-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210644-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210644-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210644-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210644-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210644-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210644-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210644-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210644-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210644-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210644-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210644-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210644-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210644-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210644-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210644-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210644-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210644-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210644-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210644-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210644-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210644-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210644-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210644-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210644-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210644-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210644-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210644-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210644-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210644-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210644-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210644-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210644-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210644-004	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210644-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210644-002	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210644-003	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210644-004	AA	1	`6a51e52b5d6a…`

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.	f9cf218c-af5e-4249-aa3b-a8555ed02278	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210644 application number: ANDA210644 ndc (product): 10702-184 ndc (product): 10702-185 ndc (product): 10702-187 ndc (product): 10702-186

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76064	ORIG	2023-11-02