An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.html 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	219267	AJENAT PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213698	ANNORA PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	214847	AUROBINDO PHARMA LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	220062	BIONPHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216368	CHARTWELL RX
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	214735	GRANULES
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216084	MSN
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204438	PH HEALTH
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216297	SCIEGEN PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	212467	SUVEN PHARMS

Top