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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020734
Company: BAXTER HLTHCARE

Products on NDA 020734

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020734

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.

Labels for NDA 020734

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

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