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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208966
Company: ALEMBIC

Products on ANDA 208966

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208966

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208966

AMANTADINE HYDROCHLORIDE

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	208966	ALEMBIC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	078720	BIONPHARMA INC
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	209171	HERITAGE PHARMA
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	214580	HUMANWELL PURACAP
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	210129	NOVELGENIX THERAPS
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	212044	RUBICON
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	071293	SANDOZ
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	209047	STRIDES PHARMA
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	211354	STRIDES PHARMA
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	070589	UPSHER SMITH LABS
AMANTADINE HYDROCHLORIDE	AMANTADINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Prescription	No	AB	208278	ZYDUS PHARMS

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