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Drugs@FDA: FDA-Approved Drugs

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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	AA	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

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	Note	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

Therapeutic Equivalents for NDA 022571

CUVPOSA

SOLUTION;ORAL; 1MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CUVPOSA	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	022571	MERZ PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213698	ANNORA PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204438	ENDO OPERATIONS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	212467	SUVEN PHARMS

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