Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204033
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;ORAL Prescription AA No 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
10/13/2015 ORIG-1 Approval

Label is not available on this site.

MEMANTINE HYDROCHLORIDE

SOLUTION;ORAL; 2MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;ORAL Prescription No AA 209955 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;ORAL Prescription No AA 204033 LANNETT CO INC
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;ORAL Prescription No AA 202790 MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;ORAL Prescription No AA 210319 SAPTALIS PHARMS

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