AMANTADINE HYDROCHLORIDE از شرکت TEVA PHARMS

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 TEVA PHARMS

Abbreviated New Drug Application (ANDA): 073115

Company: TEVA PHARMS

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

None

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
08/23/1991ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/07/1999SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1999SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/16/1998SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/11/1998SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/30/1997SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/31/1996SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/03/1993SUPPL-1 Labeling

Label is not available on this site.

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