Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205858
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYDELIG IDELALISIB 100MG TABLET;ORAL Prescription None Yes No
ZYDELIG IDELALISIB 150MG TABLET;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
07/23/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205858Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205858Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/10/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s013ltr.pdf
03/22/2018 SUPPL-12 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s012ltr.pdf
02/02/2018 SUPPL-11 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s011ltr.pdf
02/06/2018 SUPPL-10 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s010ltr.pdf
01/26/2018 SUPPL-9 Labeling-Package Insert, REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205858Orig1s009ltr.pdf
11/29/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s007ltr.pdf
01/04/2017 SUPPL-5 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205858Orig1s005ltr.pdf
09/21/2016 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205858Orig1s004ltr.pdf
01/19/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/01/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/10/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s013lbl.pdf
02/02/2018 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf
01/26/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf
01/26/2018 SUPPL-9 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s009lbl.pdf
11/29/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205858s007lbl.pdf
09/21/2016 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf
09/21/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205858s004lbl.pdf
07/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205858lbl.pdf

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