Drugs@FDA: FDA Approved Drug Products

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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 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
12/04/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208813Orig1s000TAltr.pdf

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
FARESTON TOREMIFENE CITRATE EQ 60MG BASE TABLET;ORAL Prescription Yes AB 020497 KYOWA KIRIN
TOREMIFENE CITRATE TOREMIFENE CITRATE EQ 60MG BASE TABLET;ORAL Prescription No AB 208813 RISING

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