U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208813
Company: RISING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOREMIFENE CITRATE TOREMIFENE CITRATE EQ 60MG BASE TABLET;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/04/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208813Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2026 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

TOREMIFENE CITRATE

TABLET;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOREMIFENE CITRATE TOREMIFENE CITRATE EQ 60MG BASE TABLET;ORAL Prescription No AB 212818 MSN
TOREMIFENE CITRATE TOREMIFENE CITRATE EQ 60MG BASE TABLET;ORAL Prescription No AB 208813 RISING
Back to Top