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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216297
Company: SCIEGEN PHARMS

Products on ANDA 216297

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 216297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2025	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216297

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	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

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