Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202790
Company: MACLEODS PHARMS LTD

Products on ANDA 202790

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202790

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2015	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
03/06/2018	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202790

MEMANTINE HYDROCHLORIDE

SOLUTION;ORAL; 2MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION;ORAL	Prescription	No	AA	209955	APOTEX
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION;ORAL	Prescription	No	AA	204033	CHARTWELL MOLECULAR
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION;ORAL	Prescription	No	AA	202790	MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION;ORAL	Prescription	No	AA	210319	SETON PHARMS