AMANTADINE HYDROCHLORIDE از شرکت PHARM ASSOC

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 PHARM ASSOC

Abbreviated New Drug Application (ANDA): 074509

Company: PHARM ASSOC

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE50MG/5MLSYRUP;ORALPrescription

AA

NoYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
07/17/1995ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
06/05/2012SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/26/2011SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/07/2009SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/29/2009SUPPL-9 Labeling

Label is not available on this site.

02/19/2009SUPPL-8 Labeling

Label is not available on this site.

09/03/2008SUPPL-7 Labeling

Label is not available on this site.

09/14/2007SUPPL-6 Labeling

Label is not available on this site.

05/01/2006SUPPL-4 Labeling

Label is not available on this site.

09/18/2002SUPPL-3 Labeling

Label is not available on this site.

07/20/1999SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/20/1999SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMANTADINE HYDROCHLORIDE

SYRUP;ORAL; 50MG/5ML

TE Code = AA

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE50MG/5MLSYRUP;ORALPrescriptionNoAA074170AKORN
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE50MG/5MLSYRUP;ORALPrescriptionNoAA074028ANDA REPOSITORY
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE50MG/5MLSYRUP;ORALPrescriptionNoAA075819CMP PHARMA INC
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE50MG/5MLSYRUP;ORALPrescriptionNoAA074509PHARM ASSOC
بخوانید  AMANTADINE HYDROCHLORIDE از شرکت BIONPHARMA INC
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