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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209527
Company: ACME LABS

Products on ANDA 209527

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209527

MEMANTINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209527	ACME LABS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	206528	AJANTA PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	200891	ALEMBIC
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090073	ALLIED
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090041	AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203175	AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090048	DR REDDYS LABS LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	204389	HETERO LABS LTD V
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090051	LUPIN LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202840	MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	210587	POLYGEN PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	206855	PURACAP PHARM LLC
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202350	STRIDES PHARMA
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090058	SUN PHARM
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	200022	UNICHEM
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090043	UPSHER SMITH LABS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090961	ZYDUS LIFESCIENCES
NAMENDA	MEMANTINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	021487	ABBVIE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	209527	ACME LABS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	206528	AJANTA PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	200891	ALEMBIC
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090073	ALLIED
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090041	AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	203175	AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090048	DR REDDYS LABS LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	204389	HETERO LABS LTD V
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090051	LUPIN LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	202840	MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	210587	POLYGEN PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	206855	PURACAP PHARM LLC
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	202350	STRIDES PHARMA
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090058	SUN PHARM
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	200022	UNICHEM
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090043	UPSHER SMITH LABS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090961	ZYDUS LIFESCIENCES
NAMENDA	MEMANTINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	021487	ABBVIE

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