Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204021
Company: NOVEL LABS INC

• REMS

Products on ANDA 204021

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204021Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2025	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/18/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-10	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/18/2025	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/18/2025	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/18/2025	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/18/2025	SUPPL-3	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.