AMITIZA از شرکت SUCAMPO PHARMA LLC

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

New Drug Application (NDA): 021908

Company: SUCAMPO PHARMA LLC

Summary Review

Products on NDA 021908

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMITIZA	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	None	Yes	Yes
AMITIZA	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2006	ORIG-1	Approval	Type 1 – New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021908s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021908s000_AmitizaTOC.cfm

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

01/31/2006

ORIG-1

Approval

Type 1 – New Molecular Entity

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021908s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021908s000_AmitizaTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021908Orig1s018ltr.pdf
04/26/2018	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021908Orig1s016Ltr.pdf
08/01/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021908Orig1s015ltr.pdf
10/11/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021908Orig1s013ltr.pdf
08/19/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/19/2013	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021908Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021908Orig1s011.pdf
11/26/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021908Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021908Orig1s010.pdf
02/24/2011	SUPPL-8	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021908s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021908Orig1s008.pdf
04/29/2008	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021908se1-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021908s005TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021908se1-005_SUMR.pdf
05/16/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021908s004ltr.pdf

Labels for NDA 021908

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
11/30/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf
04/26/2018	SUPPL-16	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf
08/01/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf
10/11/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf
04/19/2013	SUPPL-11	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf
11/26/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf
02/24/2011	SUPPL-8	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf
04/29/2008	SUPPL-5	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf
05/16/2007	SUPPL-4	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf
01/31/2006	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf

منبع : www.accessdata.fda.gov

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