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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090195
Company: LEADING

Products on ANDA 090195

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 090195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2023	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090195

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	202675	AUROBINDO PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040847	DR REDDYS LABS LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	207201	HERITAGE PHARMS INC
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	091182	INDOCO
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	090195	LEADING
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	PAR PHARM
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040821	RISING
GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET;ORAL	Prescription	No	AA	040844	SUN PHARM INDS LTD
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	202675	AUROBINDO PHARMA
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040847	DR REDDYS LABS LTD
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	207201	HERITAGE PHARMS INC
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	091182	INDOCO
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	090195	LEADING
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	PAR PHARM
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040821	RISING
GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	No	AA	040844	SUN PHARM INDS LTD
ROBINUL FORTE	GLYCOPYRROLATE	2MG	TABLET;ORAL	Prescription	Yes	AA	012827	CASPER PHARMA LLC

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