Application 201972

Type: ANDA
Sponsor: AUROLIFE 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;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 1.

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
A201972-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15
A201972-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2013-07-15
A201972-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15
A201972-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2013-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201972-001	AA
A201972-002	AA
A201972-003	AA
A201972-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201972-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-002	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-003	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201972-004	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Aurolife Pharma, LLC	69df20d9-b1d5-47dc-9ff0-29987284f8c7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972 ndc (product): 13107-044 ndc (product): 13107-045 ndc (product): 13107-043 ndc (product): 13107-046
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	c12c26be-ba05-4d25-a2bf-f87623c6ae57	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972 ndc (product): 71335-1036
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	dd4dbe5b-8d07-4a96-a78d-2f20da761dad	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972 ndc (product): 63187-984
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	df97ea5a-51df-453b-b1b4-edc74c718ee7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972 ndc (product): 63187-823

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-043	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-043	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-043	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-043	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-044	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-044	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-044	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-044	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-045	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-045	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-045	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-045	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-046	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-046	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma LLC	ANDA	Current
13107-046	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
13107-046	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Aurolife Pharma, LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Qua	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-496	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Qua	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-497	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Qua	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-498	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-274	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-276	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-412	OXYCODONE APAP	OXYCODONE APAP	DIRECT RX	ANDA	Current
61919-412	OXYCODONE APAP	OXYCODONE APAP	DIRECT RX	ANDA	Current
61919-437	OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHE	DIRECT RX	ANDA	Current
61919-437	OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHE	DIRECT RX	ANDA	Current
61919-524	OXYCODONE/APAP	OXYCODONE/APAP	DirectRX	ANDA	Current
63187-823	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-823	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-984	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
63187-984	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Proficient Rx LP	ANDA	Current
67296-1392	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1392	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1392	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1392	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
71335-1036	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76326	ORIG	2023-11-03