Application 040608

Type: ANDA
Sponsor: MIKART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	300MG;2.5MG	No	Yes
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	300MG;5MG	No	Yes
003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	300MG;7.5MG	No	Yes
004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	300MG;10MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
A040608-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30
A040608-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;5MG	TABLET / ORAL	RS	2005-12-30
A040608-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30
A040608-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	300MG;10MG	TABLET / ORAL	RS	2005-12-30

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040608-001	OXYCODONE AND ACETAMINOPHEN	300MG;2.5MG	TABLET / ORAL	RS	2005-12-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040608-002	OXYCODONE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	RS	2005-12-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040608-003	OXYCODONE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	RS	2005-12-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040608-004	OXYCODONE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	RS	2005-12-30	`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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nalocet	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608 ndc (product): 72245-193
oxycodone and acetaminophen	OXYCODONE AND ACETAMINOPHEN	FH2 Pharma LLC	88d97caf-bcf5-3cde-e053-2995a90acf4a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608 ndc (product): 72887-682 ndc (product): 72887-681 ndc (product): 72887-683 ndc (product): 72887-193
Prolate	OXYCODONE AND ACETAMINOPHEN	Forte Bio-Pharma LLC	9cbbfa94-37b9-9652-e053-2995a90a736b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040608 application number: ANDA040608 ndc (product): 72245-681 ndc (product): 72245-683 ndc (product): 72245-682

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 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24090-681	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
24090-681	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
24090-682	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
24090-682	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
24090-683	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
24090-683	Primlev	oxycodone and acetaminophen	Akrimax Pharmaceuticals, LLC	ANDA	Current
46672-193	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-193	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-193	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-193	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-194	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-194	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-194	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-194	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-195	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-195	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-195	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-195	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-196	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-196	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-196	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
46672-196	oxycodone and acetaminophen	oxycodone and acetaminophen	Mikart, LLC	ANDA	Current
72245-193	Nalocet	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-193	Nalocet	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-193	Nalocet	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-681	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-681	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-681	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-681	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-682	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-682	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-682	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-682	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-683	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-683	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-683	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-683	Prolate	oxycodone and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-193	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-681	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-681	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-681	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-681	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-681	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-682	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-682	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-682	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-682	oxycodone and acetaminophen	oxycodone and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-683	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-683	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-683	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-683	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current
72887-683	oxycodone and acetaminophen	oxycodone and acetaminophen tablets	FH2 Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76121	ORIG	2023-11-03