Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214178
Company: SHREE HARI INTL

Products on ANDA 214178

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214178

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