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AMINOSYN II 10% IN PLASTIC CONTAINER از شرکت ICU MEDICAL INC

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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
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AMINOSYN II 10% IN PLASTIC CONTAINER از شرکت ICU MEDICAL INC

New Drug Application (NDA): 020015

Company: ICU MEDICAL INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 10% IN PLASTIC CONTAINER AMINO ACIDS 10% (10GM/100ML) INJECTABLE;INJECTION Prescription

None

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/19/1991 ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/28/2011 SUPPL-28 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/13/2003 SUPPL-13 Labeling

Label is not available on this site.

06/30/2003 SUPPL-12 Labeling

Label is not available on this site.

11/01/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/04/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/09/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/17/1992 SUPPL-1 Labeling

Label is not available on this site.

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