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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021487
Company: ABBVIE

Products on NDA 021487

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021487

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21487ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-487_Namenda.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021487Orig1s025ltr.pdf
05/18/2016	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/07/2016	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/29/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/14/2013	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/11/2013	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/24/2013	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf
10/24/2013	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf
10/24/2013	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487s010ltr.pdf021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf
10/04/2006	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf
04/19/2006	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf
05/17/2005	SUPPL-6	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s006ltr.pdf
05/02/2005	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s004ltr.pdf
09/22/2004	SUPPL-2	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21487s002ltr.pdf

Labels for NDA 021487

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf
10/24/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf
10/24/2013	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf
10/24/2013	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf
10/16/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf

Therapeutic Equivalents for NDA 021487

NAMENDA

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	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	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	090073	CELLTRION
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	209527	RENATA
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	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	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	090073	CELLTRION
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	209527	RENATA
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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