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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201194
Company: VISTAPHARM LLC

Medication Guide

REMS

Summary Review

Products on NDA 201194

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201194

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2012	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201194s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201194Orig1s019ltr.pdf
12/15/2023	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201194Orig1s017ltr.pdf
03/04/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201194Orig1s010ltr.pdf
07/21/2021	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201194Orig1s009ltr.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201194Orig1s008ltr.pdf
09/18/2018	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf
09/18/2018	SUPPL-3	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf
12/16/2016	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201194Orig1s002ltr.pdf
06/02/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201194

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf
04/19/2024	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf
12/15/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf
12/15/2023	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf
07/21/2021	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf
03/04/2021	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf
10/07/2019	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf
09/18/2018	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf
09/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf
09/18/2018	SUPPL-3	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf
12/16/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf
12/16/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf
12/16/2016	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf
01/12/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf

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