Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204096
Company: ASTELLAS
Company: ASTELLAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ASTAGRAF XL | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
ASTAGRAF XL | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
ASTAGRAF XL | TACROLIMUS | EQ 5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/19/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204096Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204096Orig1s000OTOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/14/2023 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204096s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204096Orig1s011ltr.pdf | |
11/22/2022 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050708Orig1s054; 050709Orig1s047; 210115Orig1s006; 204096Orig1s010ltr.pdf | |
12/30/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204096Orig1s009ltr.pdf | |
06/11/2019 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204096s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204096Orig1s007ltr.pdf | |
11/29/2018 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204096s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204096Orig1s005ltr.pdf | |
12/16/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf | |
12/16/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf | |
02/28/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s002ltr.pdf | |
02/11/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/14/2023 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204096s011lbl.pdf | |
11/22/2022 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf | |
12/30/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf | |
06/11/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204096s007lbl.pdf | |
11/29/2018 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204096s005lbl.pdf | |
12/16/2015 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf | |
12/16/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf | |
12/16/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf | |
02/28/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf | |
07/19/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf |
ASTAGRAF XL
CAPSULE, EXTENDED RELEASE;ORAL; EQ 0.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASTAGRAF XL | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASTAGRAF XL | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASTAGRAF XL | TACROLIMUS | EQ 5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |