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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207012
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG 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
09/10/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207012Orig1s000ltr.pdf

SORAFENIB TOSYLATE

TABLET;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEXAVAR SORAFENIB TOSYLATE EQ 200MG BASE TABLET;ORAL Prescription Yes AB 021923 BAYER HLTHCARE
SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG BASE TABLET;ORAL Prescription No AB 216073 DR REDDYS
SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG BASE TABLET;ORAL Prescription No AB 207012 MYLAN
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