CUVPOSA از شرکت MERZ PHARMS

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): 022571

Company: MERZ PHARMS

Summary Review

Products on NDA 022571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUVPOSA	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2010	ORIG-1	Approval	Type 3 – New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022571s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571s000_cuvposa_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000SumR.pdf

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

07/28/2010

ORIG-1

Approval

Type 3 – New Dosage Form

STANDARD; Orphan

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022571s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571s000_cuvposa_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022571s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022571Orig1s008ltr.pdf
05/18/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022571Orig1s006ltr.pdf
02/08/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/06/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022571Orig1s004ltr.pdf
05/21/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022571Orig1s003ltr.pdf
11/08/2012	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022571

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
02/23/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022571s008lbl.pdf
05/18/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf
11/06/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf
05/21/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf
07/28/2010	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf

منبع : www.accessdata.fda.gov

CUVPOSA از شرکت MERZ PHARMS