AMANTADINE HYDROCHLORIDE از شرکت SANDOZ

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 SANDOZ

Abbreviated New Drug Application (ANDA): 071293

Company: SANDOZ

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

AB

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
02/18/1987ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
09/11/2019SUPPL-40 Labeling-Container/Carton Labels

Label is not available on this site.

09/11/2019SUPPL-38 Labeling-Package Insert

Label is not available on this site.

03/25/2009SUPPL-31 Labeling

Label is not available on this site.

11/20/2008SUPPL-29 Labeling

Label is not available on this site.

04/01/2008SUPPL-28 Labeling

Label is not available on this site.

05/11/2004SUPPL-21 Labeling

Label is not available on this site.

11/08/2002SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/08/2002SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/2002SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/2002SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

02/07/2002SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/2002SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/1997SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/07/1997SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/25/1996SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/25/1996SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/25/1996SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/25/1996SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/25/1996SUPPL-7 Labeling

Label is not available on this site.

01/25/1996SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/28/1994SUPPL-5 Labeling

Label is not available on this site.

09/11/1991SUPPL-4 Labeling

Label is not available on this site.

06/27/1991SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/14/1989SUPPL-2 Labeling

Label is not available on this site.

03/30/1988SUPPL-1 Manufacturing (CMC)

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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