Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209035
Company: STRIDES PHARMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/09/2017 ORIG-1 Approval STANDARD

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 207571 NEWGEN PHARMS LLC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 209035 STRIDES PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 076186 USL PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208096 WATSON LABS INC

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