Application 090733

Type: ANDA
Sponsor: VINTAGE 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;2.5MG	No	No

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
A090733-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL			2013-07-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090733-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		2013-07-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090733-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090733-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090733-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090733-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090733-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090733-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090733-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090733-001	AA	1	`ea99ee380514…`

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 2 of 4 · 63 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	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	RedPharm Drug	2c6014de-8901-9d83-e063-6294a90ad37b	2025-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Aurolife Pharma, LLC	69df20d9-b1d5-47dc-9ff0-29987284f8c7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Epic Pharma, LLC	700a229f-dc2d-7086-e053-2991aa0aec91	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Alvogen, Inc.	900ec197-720e-5428-b526-055b7756aa4a	2025-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	e0d06ec7-9846-4e04-8660-5fd6b2b8e423	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	American Health Packaging	79bb61d7-8836-4ce7-91bc-9463efbad9cf	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Granules Pharmaceuticals Inc.	cc966d57-7cdc-4de3-bbcf-718e2fce9cb7	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
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	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals LLC	c5cc2e88-aa00-46bd-91dc-901c3a7c899c	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	683d563f-0686-4964-8183-cf08758cae71	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	b4cf62af-b5d3-4825-9743-9ec3137164e8	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	42777191-0454-4ccb-8fc3-8b18b0ee43f7	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	90a11364-fc42-e94e-e053-2a95a90a9782	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	a8206207-ad09-83df-e053-2995a90a78b7	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	71c7a627-6ed9-4f49-8cdc-b3228c021e64	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	e4e27022-581e-ba8c-e053-2a95a90a1ae4	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Quality Care products LLC	3f2b939c-2206-469b-85a4-b0ee9ba25be8	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	223fe2b4-aa12-81fd-e063-6394a90a6c08	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	c12c26be-ba05-4d25-a2bf-f87623c6ae57	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone and Acetaminophen

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
0603-4978	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0603-4978	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical	ANDA	Current
0603-4978	Oxycodone and Acetaminophen	Oxycodone hydrochloride and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76173	ORIG	2023-11-03