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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207201
Company: APPCO

Products on ANDA 207201

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	AA	No	No
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/03/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207201Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2025	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 207201

GLYCOPYRROLATE

TABLET;ORAL; 1MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	203657	ALEMBIC
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	207201	APPCO
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	202675	AUROBINDO PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040847	CHARTWELL RX
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	091413	NATCO
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	090020	OXFORD PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040653	PH HEALTH
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	212696	QUAGEN
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	091182	REGCON HOLDINGS
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040821	RISING
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040844	SUN PHARM INDS LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	090195	VELZEN PHARMA PVT
ROBINUL	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	Yes	AA	012827	CASPER PHARMA LLC

TABLET;ORAL; 2MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	203657	ALEMBIC
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	207201	APPCO
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	202675	AUROBINDO PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040847	CHARTWELL RX
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	091413	NATCO
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	090020	OXFORD PHARMS
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040653	PH HEALTH
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	212696	QUAGEN
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	091182	REGCON HOLDINGS
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040821	RISING
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040844	SUN PHARM INDS LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	090195	VELZEN PHARMA PVT
ROBINUL FORTE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	Yes	AA	012827	CASPER PHARMA LLC

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