Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211353
Company: TEVA PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOFOSBUVIR SOFOSBUVIR 400MG 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
01/27/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211353Orig1s000ltr.pdf

SOFOSBUVIR

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SOFOSBUVIR SOFOSBUVIR 400MG TABLET;ORAL Prescription No AB 211353 TEVA PHARMS USA INC
SOVALDI SOFOSBUVIR 400MG TABLET;ORAL Prescription Yes AB 204671 GILEAD SCIENCES INC

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