Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214284
Company: ALEMBIC

Products on ANDA 214284

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214284

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2020	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
07/10/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214284

AMANTADINE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	214284	ALEMBIC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	210215	POM PHARMA
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	209035	STRIDES PHARMA
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076186	UPSHER SMITH LABS
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208096	WATSON LABS INC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	218598	ZHEJIANG JUTAI PHARM