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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076186
Company: UPSHER SMITH LABS

Products on ANDA 076186

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2002	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-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2017	SUPPL-22	Labeling-Container/Carton Labels		Label is not available on this site.
01/18/2012	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/04/2009	SUPPL-12	Labeling		Label is not available on this site.
02/09/2009	SUPPL-10	Labeling		Label is not available on this site.
11/19/2007	SUPPL-9	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076186

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

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