Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204752
Company: NOVEL LABS INC

• REMS

Products on ANDA 204752

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204752

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2015	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
09/18/2018	SUPPL-1	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 204752

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	205177	ANI PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	202773	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	Yes	AB	200534	GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	204752	NOVEL LABS INC