AMANTADINE HYDROCHLORIDE از شرکت ANDA REPOSITORY

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 ANDA REPOSITORY

Abbreviated New Drug Application (ANDA): 074028

Company: ANDA REPOSITORY

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
06/28/1993ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
01/18/2012SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/22/2006SUPPL-12 Labeling

Label is not available on this site.

08/13/2002SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/1998SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/04/1998SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/04/1998SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/12/1997SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/22/1995SUPPL-4 Labeling

Label is not available on this site.

01/25/1996SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/12/1995SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/27/1994SUPPL-1 Labeling

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
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