AMANTADINE HYDROCHLORIDE از شرکت BIONPHARMA INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AMANTADINE HYDROCHLORIDE از شرکت BIONPHARMA INC

Abbreviated New Drug Application (ANDA): 078720

Company: BIONPHARMA INC

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescription

AB

NoYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
05/29/2008ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/30/2017SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/01/2011SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/25/2009SUPPL-1 Labeling

Label is not available on this site.

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL; 100MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB208966ALEMBIC PHARMS LTD
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB078720BIONPHARMA INC
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB209171HERITAGE PHARMA
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB210129NOVELGENIX THERAPS
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB212044RUBICON
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB071293SANDOZ
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB209047STRIDES PHARMA
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB070589UPSHER SMITH LABS
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB208107WATSON LABS INC
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE100MGCAPSULE;ORALPrescriptionNoAB208278ZYDUS PHARMS
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