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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202116
Company: ALVOGEN

REMS

Products on ANDA 202116

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	AB	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202116

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/2011	ORIG-1	Approval	Not Applicable			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-5	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 202116

OXYCODONE HYDROCHLORIDE

TABLET;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	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	207418	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	207418	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

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