Application 201278

Type: ANDA
Sponsor: RHODES PHARMS

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 1.

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
A201278-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2014-08-28
A201278-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28
A201278-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2014-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201278-001	AA
A201278-002	AA
A201278-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2014-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201278-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2014-08-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201278-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201278-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201278-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201278-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201278-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201278-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201278-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201278-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201278-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201278-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201278-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201278-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201278-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201278-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201278-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201278-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201278-001	AA	1	`8072bd15b7f6…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	ac6b4a26-7ead-458e-8a3d-591aa0709343	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	ef2c1fe2-75dd-43cf-871d-540c5e36d363	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 71335-1420
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	fcb09a57-76d8-413c-801b-8d8ea0c3f1db	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 71335-1492
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	1c793d37-cbc9-4d76-a84a-d076b5101143	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 71335-1472
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	3cd2e535-dd11-4bfb-e063-6394a90a9fbc	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4d9e7c39-3e71-48c7-87c7-302db1835f11	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 71335-1909
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	e6c47385-638a-41cd-93d9-b7ee205aa094	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 63629-9501
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Rhodes Pharmaceuticals LLC	5999f3c3-3225-4d24-82cd-0b8d7a309587	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 42858-103 ndc (product): 42858-104 ndc (product): 42858-102
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	639aba0b-1ef6-415f-9732-ebf52bcc1b86	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 63629-8876
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	79c3af61-19e7-40e5-bd20-2cea52f0bd3a	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Oxycodone/APAP	OXYCODONE/APAP	Direct_Rx	e84245ca-957f-e85b-e053-2a95a90a836b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 72189-375
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	RedPharm Drug	2c6014de-8901-9d83-e063-6294a90ad37b	2025-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278
Percocet	OXYCODONE/APAP	Direct_Rx	ee151649-b52a-0a51-e053-2a95a90a6c35	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 72189-397
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	ad03068c-1af4-46ce-bdea-c2745b1c1e52	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 63187-824
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	3e89f02d-b6e7-4641-82d4-f756518a8914	2022-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 76420-209
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	0dcb491a-54e8-486b-9575-788525a178cf	2021-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201278 application number: ANDA201278 ndc (product): 76420-136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-102	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-102	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-102	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-102	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-103	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-103	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-103	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-103	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-104	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-104	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-104	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-104	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
63187-824	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-824	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-824	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63629-8876	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-8876	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-8879	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-8879	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-9501	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1420	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1472	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1472	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1472	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1473	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1473	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1473	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1492	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1492	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1909	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
72189-375	Oxycodone/APAP	Oxycodone/APAP	Direct_Rx	ANDA	Current
72189-375	Oxycodone/APAP	Oxycodone/APAP	Direct_Rx	ANDA	Current
72189-397	Percocet	Oxycodone/APAP	Direct_Rx	ANDA	Current
72189-398	Percocet	Oxycodone/APAP	Direct_Rx	ANDA	Current
72189-398	Percocet	Oxycodone/APAP	Direct_Rx	ANDA	Current
76420-136	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Asclemed USA, Inc.	ANDA	Current
76420-209	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76159	ORIG	2023-11-03
32091	ORIG	2014-09-03