Application 203864

Type: ANDA
Sponsor: EPIC PHARMA 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;5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203864-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2018-07-02
A203864-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02
A203864-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2018-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203864-001	AA
A203864-002	AA
A203864-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203864-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A203864-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203864-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203864-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203864-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203864-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203864-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203864-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203864-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203864-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203864-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203864-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203864-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203864-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203864-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203864-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203864-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203864-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203864-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203864-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203864-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203864-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203864-001	AA	1	`1e350fbaab3a…`

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	Epic Pharma, LLC	700a229f-dc2d-7086-e053-2991aa0aec91	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203864 application number: ANDA203864 ndc (product): 42806-116 ndc (product): 42806-114 ndc (product): 42806-115

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-114	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-114	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-114	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-114	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-115	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-115	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-115	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-115	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-116	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-116	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-116	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current
42806-116	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Epic Pharma, LLC	ANDA	Current