Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203573
Company: VINTAGE PHARMS

• REMS

Products on ANDA 203573

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203573Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-6	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/16/2016	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.