Application 040778

Type: ANDA
Sponsor: AMNEAL PHARMS NY

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;10MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No

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

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
A040778-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA		2007-11-27
A040778-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA		2014-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040778-001	AA
A040778-002	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 3 · 86 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	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040778-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040778-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040778-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040778-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040778-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040778-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040778-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040778-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040778-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040778-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040778-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040778-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040778-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040778-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040778-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040778-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040778-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040778-002	AA	1	`74a2ff9319b5…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	AvPAK	7055acd5-1cbb-397e-e053-2a91aa0a3852	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778 ndc (product): 50268-645 ndc (product): 50268-646
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	d61e0ff4-e04b-4dc6-b818-6a8f46e99b5e	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778 ndc (product): 53746-204
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals LLC	c5cc2e88-aa00-46bd-91dc-901c3a7c899c	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778 ndc (product): 65162-207
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	6253b3ae-bb52-4532-8d1f-756c0b1577c7	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778 ndc (product): 63187-721

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-619	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rebel Distributors Corp	ANDA	Current
35356-937	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42291-646	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvKARE, Inc.	ANDA	Current
50268-645	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
50268-645	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
50268-646	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
50268-646	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
52959-119	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	H.J. Harkins Company, Inc.	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-204	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
55700-373	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61502-915	OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	EPM Packaging Inc	ANDA	Current
61919-475	OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHE	Direct_Rx	ANDA	Current
61919-615	OXYCODONE APAP	OXYCODONE APAP	DIRECT RX	ANDA	Current
63187-721	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-721	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63739-217	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	McKesson Corporation	ANDA	Current
63739-217	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	McKesson Corporation dba SKY Packaging	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current
65162-207	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76300	ORIG	2023-11-03