AMANTADINE HYDROCHLORIDE از شرکت UPSHER SMITH LABS

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 UPSHER SMITH LABS

Abbreviated New Drug Application (ANDA): 070589

Company: UPSHER SMITH LABS

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
01/07/1987ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
01/11/2012SUPPL-45 Labeling-Package Insert

Label is not available on this site.

07/28/2014SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/05/2009SUPPL-40 Labeling

Label is not available on this site.

02/09/2009SUPPL-38 Labeling

Label is not available on this site.

11/19/2007SUPPL-37 Labeling

Label is not available on this site.

11/17/2004SUPPL-29 Labeling

Label is not available on this site.

10/31/2003SUPPL-26 Labeling

Label is not available on this site.

03/26/2003SUPPL-24 Labeling

Label is not available on this site.

12/16/1997SUPPL-21 Labeling

Label is not available on this site.

10/18/1996SUPPL-20 Labeling

Label is not available on this site.

10/18/1996SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/18/1996SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/18/1996SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/18/1996SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/09/1995SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/09/1995SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/24/1993SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/24/1993SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/24/1993SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/24/1993SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/24/1993SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/16/1991SUPPL-8 Labeling

Label is not available on this site.

02/26/1991SUPPL-7 Labeling

Label is not available on this site.

02/26/1991SUPPL-6 Labeling

Label is not available on this site.

03/27/1989SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/26/1988SUPPL-4 Labeling

Label is not available on this site.

05/05/1988SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/07/1987SUPPL-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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