An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207621
Company: PFIZER

Medication Guide

FDA Press Release

FDA has determined that this product has abuse-deterrent properties

REMS

Summary Review

Products on NDA 207621

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	1.2MG;10MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	2.4MG;20MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	3.6MG;30MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	4.8MG;40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	7.2MG;60MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	9.6MG;80MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207621

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2016	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207621Orig1toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207621Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2017	SUPPL-5	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207621Orig1s005ltr.pdf
12/16/2016	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s004ltr.pdf
09/30/2016	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207621Orig1s001ltr.pdf

Labels for NDA 207621

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2016	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf
08/19/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s000lbl.pdf

Top