Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204037
Company: HIKMA

• REMS

Products on ANDA 204037

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2013	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
12/22/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/09/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/09/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/09/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/09/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/09/2025	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/09/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/04/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204037

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	207511	HIBROW HLTHCARE
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