Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208813
Company: RISING
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 | 212818 | MSN |
TOREMIFENE CITRATE | TOREMIFENE CITRATE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 208813 | RISING |