Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204929
Company: RISING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
03/17/2017 ORIG-1 Approval

Label is not available on this site.

ZILEUTON

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204929 RISING PHARMS INC
ZYFLO CR ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022052 CHIESI USA INC

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