Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210115
Company: ASTELLAS
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 |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050708s055,210115s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050708Orig1s055;210115Orig1s007ltr.pdf | |
| 11/22/2022 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210115s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050708Orig1s054; 050709Orig1s047; 210115Orig1s006; 204096Orig1s010ltr.pdf | |
| 07/16/2021 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050708s053,050709s045,210115s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050708Orig1s053; 050709Orig1s045; 210115Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/050708Orig1s053; 050709Orig1s045; 210115Orig1s005.pdf | |
| 12/30/2020 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050708s052,050709s044,210115s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050708Orig1s052,%20050709Orig1s044,%20210115Orig1s004ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050708s055,210115s007lbl.pdf | |
| 11/22/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210115s006lbl.pdf | |
| 07/16/2021 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050708s053,050709s045,210115s005lbl.pdf | |
| 12/30/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050708s052,050709s044,210115s004lbl.pdf | |
| 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 |