Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204979
Company: ANI PHARMS

• REMS

Products on ANDA 204979

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204979Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2020	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/11/2020	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-4	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/11/2020	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 204979

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	208593	ABHAI LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211748	ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204979	ANI PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	209021	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	200535	GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204037	HIKMA
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206914	PHARM ASSOC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213761	QUAGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207511	WES PHARMA INC