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AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER از شرکت HOSPIRA

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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
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER از شرکت HOSPIRA

New Drug Application (NDA): 019681

Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 3.5%;25GM/100ML INJECTABLE;INJECTION Discontinued

None

No No
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 3.5%;5GM/100ML INJECTABLE;INJECTION Discontinued

None

No No
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;10GM/100ML INJECTABLE;INJECTION Discontinued

None

No No
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;20GM/100ML INJECTABLE;INJECTION Discontinued

None

No No
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;25GM/100ML INJECTABLE;INJECTION Discontinued

None

No No
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;25GM/100ML INJECTABLE;INJECTION Discontinued

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
11/01/1988 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
02/19/2003 SUPPL-20 Manufacturing (CMC)-Control

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19681scs020ltr.pdf

11/08/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-18 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf

10/29/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-15 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19681slr015,018ltr.pdf

08/20/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/30/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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