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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208278
Company: ZYDUS PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/31/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

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 PHARMS LTD
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 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 070589 UPSHER SMITH LABS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 208107 WATSON LABS INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 208278 ZYDUS PHARMS
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