Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211708
Company: GRANULES

• REMS

Products on ANDA 211708

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/18/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/29/2023	SUPPL-2	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.