Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040778
Company: AMNEAL PHARMS NY

• REMS

Products on ANDA 040778

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	AA	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040778

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-32	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/13/2024	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2024	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2024	SUPPL-29	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/03/2024	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/04/2021	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-16	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/21/2018	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-13	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/29/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040778

OXYCODONE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	210644	ABHAI LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	201447	ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	202677	ALVOGEN
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	040778	AMNEAL PHARMS NY
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	207419	ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	201972	AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	209385	ELITE LABS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	203864	EPIC PHARMA LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	211708	GRANULES
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	207333	LANNETT CO INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	204407	NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	201278	RHODES PHARMS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	040545	SPECGX LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	207510	WES PHARMA INC
PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Prescription	No	AA	040330	ENDO OPERATIONS

TABLET;ORAL; 325MG;7.5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	210644	ABHAI LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	201447	ACTAVIS ELIZABETH
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	202677	ALVOGEN
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	040778	AMNEAL PHARMS NY
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	207419	ASCENT PHARMS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	201972	AUROLIFE PHARMA LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	209385	ELITE LABS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	203864	EPIC PHARMA LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	211708	GRANULES
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	204407	NOVEL LABS INC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	201278	RHODES PHARMS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	040545	SPECGX LLC
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	207510	WES PHARMA INC
PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Prescription	No	AA	040330	ENDO OPERATIONS