0

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% 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

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE

New Drug Application (NDA): 020734

Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;10GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;25GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 2.75%;5GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;10GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;20GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;25GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 4.25%;5GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;10GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;15GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;20GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;25GM/100ML INJECTABLE;INJECTION Prescription

None

No No
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;35GM/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
09/29/1997 ORIG-1 Approval

Type 4 – New Combination

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
04/13/2021 SUPPL-37 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020734s037lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020678Orig1s042, 020734Orig1s037, 204508Orig1s015ltr.pdf

10/12/2018 SUPPL-34

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020734s034lbl.pdf

01/19/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/27/2016 SUPPL-25 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020734s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020678Orig1s027,020734Orig1s025ltr.pdf

09/15/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/02/2009 SUPPL-19 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020734s019ltr.pdf

01/23/2004 SUPPL-13 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr013ltr.pdf

05/21/2003 SUPPL-12 Manufacturing (CMC)-Control

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs012ltr.pdf

07/25/2002 SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf

07/25/2002 SUPPL-10 Manufacturing (CMC)-Control

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf

02/15/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/2000 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/12/2000 SUPPL-3 Efficacy-Labeling Change With Clinical Data

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20734S03LTR.PDF

05/25/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/15/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/13/2021 SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020734s037lbl.pdf
10/12/2018 SUPPL-34

Manufacturing (CMC)

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020734s034lbl.pdf
09/27/2016 SUPPL-25

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020734s025lbl.pdf
بخوانید  ACYCLOVIR از شرکت CADILA
برچسب‌ها:, , , , , , , , , , ,

نظرات کاربران