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BRANCHAMIN 4% IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

تصویر پیدا نشد !

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

BRANCHAMIN 4% IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

New Drug Application (NDA): 018684

Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRANCHAMIN 4% IN PLASTIC CONTAINER AMINO ACIDS 4% (4GM/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
09/28/1984 ORIG-1 Approval

Type 3 – New Dosage Form

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
04/24/2003 SUPPL-20 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18684slr020ltr.pdf

08/14/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/14/2001 SUPPL-16 Labeling

Label is not available on this site.

04/29/1997 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1992 SUPPL-8 Labeling

Label is not available on this site.

03/26/1991 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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