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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212477
Company: GILEAD SCIENCES INC

Products on NDA 212477

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212477

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) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212477s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212477Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212477Orig1s000TOC.cfm

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
03/05/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205834Orig1s032, 212477Orig1s003ltr.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

Labels for NDA 212477

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf
03/05/2020	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205834s032,212477s003lbl.pdf
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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