Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050708
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROGRAF | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| PROGRAF | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| PROGRAF | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/08/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050708_prograf_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050708s055,010115s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050708Orig1s055;210115Orig1s007ltr.pdf | |
| 11/22/2022 | SUPPL-54 | 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 | |
| 07/16/2021 | SUPPL-53 | 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-52 | 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, 050709Orig1s044, 210115Orig1s004ltr.pdf | |
| 06/11/2019 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050708s050,050709s042,210115s002lbl.pdf | |
| 12/02/2018 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050708s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050708s048ltr.pdf | |
| 05/24/2018 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
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 | |
| 05/19/2015 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf | |
| 03/19/2014 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/2013 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf | |
| 01/28/2013 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2012 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf | |
| 07/05/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf | |
| 02/06/2012 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf | |
| 07/14/2011 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf | |
| 07/14/2011 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf | |
| 02/13/2009 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf | |
| 05/19/2009 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050708Orig1s027_StatR.pdf | |
| 04/27/2006 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf | |
| 12/13/2005 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf |
| 03/29/2006 | SUPPL-24 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf |
| 06/16/2004 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf | |
| 10/24/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/2001 | SUPPL-16 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf | |
| 07/25/2001 | SUPPL-15 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf | |
| 05/08/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/2000 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf | |
| 08/24/1998 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/24/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf | |
| 04/20/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1997 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/22/1997 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/14/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050708s055,010115s007lbl.pdf | |
| 11/22/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf | |
| 07/16/2021 | SUPPL-53 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050708s053,050709s045,210115s005lbl.pdf | |
| 12/30/2020 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050708s052,050709s044,210115s004lbl.pdf | |
| 06/11/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050708s050,050709s042,210115s002lbl.pdf | |
| 12/02/2018 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050708s048lbl.pdf | |
| 05/24/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210115s000,050708s047,050709s040lbl.pdf | |
| 05/19/2015 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf | |
| 09/04/2013 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf | |
| 08/14/2012 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf | |
| 07/05/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf | |
| 02/06/2012 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf | |
| 07/14/2011 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf | |
| 07/14/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf | |
| 05/19/2009 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf | |
| 02/13/2009 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf | |
| 04/27/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf | |
| 06/16/2004 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf | |
| 07/25/2001 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf | |
| 07/25/2001 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf | |
| 12/01/2000 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf | |
| 08/24/1998 | SUPPL-10 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf |
PROGRAF
CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | BELCHER |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | BELCHER |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213112 | CONCORD BIOTECH LTD |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050708 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 203740 | ALKEM LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206651 | BELCHER |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212297 | BIOCON PHARMA |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090509 | DR REDDYS LABS LTD |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206662 | GLENMARK PHARMS LTD |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210929 | HANGZHOU ZHONGMEI |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090596 | MYLAN |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090802 | PANACEA |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065461 | SANDOZ |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090687 | STRIDES PHARMA |