Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212467
Company: SUVEN PHARMS

Products on ANDA 212467

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 212467

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/2022/212467Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 212467

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	214847	AUROBINDO PHARMA LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216368	CHARTWELL RX
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204438	ENDO OPERATIONS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	214735	GRANULES
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	216297	SAPTALIS PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION;ORAL	Prescription	No	AA	212467	SUVEN PHARMS