Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208173
Company: HIKMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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 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 090073 CELLTRION
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 208173 HIKMA
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 212947 NINGBO
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 200155 TORRENT
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
NAMENDA MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021487 ALLERGAN

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 090073 CELLTRION
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 208173 HIKMA
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 212947 NINGBO
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 200155 TORRENT
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
NAMENDA MEMANTINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021487 ALLERGAN

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