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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204459
Company: AUROLIFE PHARMA LLC

REMS

Products on ANDA 204459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2016	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
03/04/2021	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/16/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/16/2021	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-2	REMS - PROPOSAL - D-N-A		Label is not available on this site.
02/16/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204459

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	210175	ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	204459	AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203601	AVANTHI INC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	201187	EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090964	HIKMA
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091443	TEVA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	210175	ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	204459	AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	203601	AVANTHI INC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	201187	EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090964	HIKMA
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	091443	TEVA

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