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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074170
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;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
10/28/1994 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2014 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

06/17/2011 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/18/2009 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMANTADINE HYDROCHLORIDE

SYRUP;ORAL; 50MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074170 AKORN
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074028 CHARTWELL RX
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 075819 CMP PHARMA INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 214178 NOVELGENIX THERAPS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Prescription No AA 074509 PHARM ASSOC
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