Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 210115
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROGRAF TACROLIMUS EQ 0.2MG BASE/PACKET FOR SUSPENSION;ORAL Prescription None Yes No
PROGRAF TACROLIMUS EQ 1MG BASE/PACKET FOR SUSPENSION;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
05/24/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115Orig1s000,050708Orig1s047,050709Orig1s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210115Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/11/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050708s050,050709s042,210115s002lbl.pdf
12/02/2018 SUPPL-1 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210115s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/11/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050708s050,050709s042,210115s002lbl.pdf
05/24/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English