Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205365
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;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

CAPSULE, EXTENDED RELEASE;ORAL; 7MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205825 AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205784 ANCHEN PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205365 ANI PHARMS INC
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206135 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203293 ZYDUS PHARMS
NAMENDA XR MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022525 FOREST LABS LLC

CAPSULE, EXTENDED RELEASE;ORAL; 14MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205825 AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205784 ANCHEN PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205365 ANI PHARMS INC
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206135 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203293 ZYDUS PHARMS
NAMENDA XR MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022525 FOREST LABS LLC

CAPSULE, EXTENDED RELEASE;ORAL; 21MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205825 AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205784 ANCHEN PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205365 ANI PHARMS INC
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206135 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203293 ZYDUS PHARMS
NAMENDA XR MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022525 FOREST LABS LLC

CAPSULE, EXTENDED RELEASE;ORAL; 28MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205825 AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205784 ANCHEN PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205365 ANI PHARMS INC
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206135 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203293 ZYDUS PHARMS
NAMENDA XR MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022525 FOREST LABS LLC

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