U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212670
Company: STRIDES PHARMA
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
12/16/2019 ORIG-1 Approval STANDARD

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 211390 DASH PHARMS
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204929 RISING
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212670 STRIDES PHARMA
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211043 TEVA PHARMS USA
ZYFLO CR ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022052 CHIESI
Back to Top