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

Abbreviated New Drug Application (ANDA): 213698
Company: ANNORA PHARMA

Products on ANDA 213698

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213698

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213698Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 213698

GLYCOPYRROLATE

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	PAR PHARM INC
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	212467	SUVEN PHARMS

Top