Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207621
Company: PFIZER INC
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
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
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

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