Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074170
Company: AUROBINDO PHARMA USA

Products on ANDA 074170

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074170

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
07/10/2025	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/04/2014	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
06/17/2011	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/18/2009	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 074170

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	AUROBINDO PHARMA USA
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	074509	PHARM ASSOC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP;ORAL	Prescription	No	AA	075060	PHARMOBEDIENT
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	50MG/5ML	SYRUP;ORAL	Prescription	No	AA	214178	SHREE HARI INTL