Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020333
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AGRYLIN | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| AGRYLIN | ANAGRELIDE HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/14/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2021 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020333s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020333Orig1s027ltr.pdf | |
| 02/28/2020 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020333s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020333Orig1s026ltr.pdf | |
| 12/19/2018 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020333Orig1s025Ltr.pdf | |
| 03/20/2018 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020333Orig1s024ltr.pdf | |
| 07/14/2015 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020333Orig1s023ltr.pdf | |
| 10/30/2014 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s022ltr.pdf | |
| 02/07/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020333Orig1s021ltr.pdf | |
| 07/17/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020333Orig1s020ltr.pdf | |
| 11/22/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s019ltr.pdf | |
| 01/31/2011 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020333s017ltr.pdf | |
| 06/30/2010 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020333s016ltr.pdf | |
| 07/09/2009 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020333s015ltr.pdf | |
| 06/17/2008 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020333s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020333Orig1s013.pdf | |
| 12/17/2004 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s010ltr.pdf | |
| 12/10/2004 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf | |
| 12/10/2004 | SUPPL-8 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20333s008,009ltr.pdf | |
| 10/10/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/19/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1998 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20333S2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20333-S002_Agrylin.pdf | |
| 11/07/1997 | 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 |
|---|---|---|---|---|---|
| 10/13/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020333s027lbl.pdf | |
| 02/28/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020333s026lbl.pdf | |
| 12/19/2018 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s025lbl.pdf | |
| 03/20/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020333s024lbl.pdf | |
| 07/14/2015 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020333s023lbl.pdf | |
| 10/30/2014 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s022lbl.pdf | |
| 02/07/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020333s021lbl.pdf | |
| 07/17/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020333s020lbl.pdf | |
| 11/22/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s019lbl.pdf | |
| 01/31/2011 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020333s017lbl.pdf | |
| 06/30/2010 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020333s016lbl.pdf | |
| 07/09/2009 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf | |
| 06/17/2008 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020333s013lbl.pdf | |
| 12/17/2004 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s010lbl.pdf | |
| 12/10/2004 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf | |
| 12/10/2004 | SUPPL-8 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20333s008,009lbl.pdf | |
| 12/16/1998 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20333S2lbl.pdf |
AGRYLIN
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 |
|---|---|---|---|---|---|---|---|---|
| AGRYLIN | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 020333 | TAKEDA PHARMS USA |
| ANAGRELIDE HYDROCHLORIDE | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076910 | IMPAX LABS |
| ANAGRELIDE HYDROCHLORIDE | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076468 | IVAX SUB TEVA PHARMS |
| ANAGRELIDE HYDROCHLORIDE | ANAGRELIDE HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209151 | TORRENT |