Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021487
Company: ALLERGAN SALES LLC
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
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
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

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 PHARMS LTD
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 090961 CADILA
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209527 CSPC OUYI
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 091585 JUBILANT GENERICS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207236 LANNETT CO INC
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 079225 MYLAN PHARMS INC
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 PHARMA GLOBAL
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090052 TEVA PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 200155 TORRENT
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 200022 UNICHEM LABS LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090043 UPSHER SMITH LABS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090073 WOCKHARDT LTD
NAMENDA MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021487 ALLERGAN SALES LLC

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 PHARMS LTD
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 090961 CADILA
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209527 CSPC OUYI
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 091585 JUBILANT GENERICS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207236 LANNETT CO INC
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 079225 MYLAN PHARMS INC
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 PHARMA GLOBAL
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090052 TEVA PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 200155 TORRENT
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 200022 UNICHEM LABS LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090043 UPSHER SMITH LABS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090073 WOCKHARDT LTD
NAMENDA MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021487 ALLERGAN SALES LLC

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