Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200792
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 7.5MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 40MG TABLET, 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
10/24/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200792Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2016 SUPPL-2 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-1 REMS-Modified

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English