Drugs@FDA: FDA Approved Drug Products

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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
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
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

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