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Drugs@FDA: FDA-Approved Drugs

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

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 PHARMS LTD
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 212407 EDENBRIDGE PHARMS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 210215 NOVELGENIX THERAPS
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
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