Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212477
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HARVONI LEDIPASVIR; SOFOSBUVIR 33.75MG;150MG/PACKET PELLETS;ORAL Prescription None Yes No
HARVONI LEDIPASVIR; SOFOSBUVIR 45MG;200MG/PACKET PELLETS;ORAL Prescription None Yes 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
08/28/2019 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212477s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212477Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/2019 SUPPL-4 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212477Orig1s004ltr.pdf
11/15/2019 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s028,212477s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205834Orig1s028, 212477Orig1s002ltr.pdf
09/19/2019 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s031,212477s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205834Orig1s031,%20212477Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s028,212477s002lbl.pdf
09/19/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205834s031,212477s001lbl.pdf
08/28/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212477s000lbl.pdf

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