AGRYLIN از شرکت TAKEDA PHARMS USA

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AGRYLIN از شرکت TAKEDA PHARMS USA

New Drug Application (NDA): 020333

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AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued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
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
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
حتما بخوانید : CEPHRADINE از شرکت TEVA
بخوانید  BETAMETHASONE DIPROPIONATE از شرکت ALPHARMA US PHARMS
به بالای صفحه بردن