← FDA DRUG APPROVALS

FDA NDA · NDA020734

CLINIMIX

leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020734
TYPE
NDA
ORIGINAL APPROVAL
1997-09-29
LATEST ACTION
2021-04-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 8%, DEXTROSE 14GM/100ML · INJECTABLE · INJECTION
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5%, DEXTROSE 25GM/100ML · INJECTABLE · INJECTION
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5%, DEXTROSE 15GM/100ML · INJECTABLE · INJECTION
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 4.25%, DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 2.75%, DEXTROSE 25GM/100ML · INJECTABLE · INJECTION
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 4.25%, DEXTROSE 25GM/100ML · INJECTABLE · INJECTION
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 2.75%, DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5%, DEXTROSE 35GM/100ML · INJECTABLE · INJECTION
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5%, DEXTROSE 20GM/100ML · INJECTABLE · INJECTION
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 4.25%, DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5%, DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 4.25%, DEXTROSE 20GM/100ML · INJECTABLE · INJECTION
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 2.75%, DEXTROSE 10GM/100ML · INJECTABLE · INJECTION

Approval history

2021-04-13Labeling · Supplement 37 · standard — Letter ↗AP
2018-10-12Manufacturing (CMC) · Supplement 34 · standard — Label ↗AP
2016-09-27Labeling · Supplement 25 · standard — Letter ↗AP
2016-01-19Manufacturing (CMC) · Supplement 28 · standardAP
2014-09-15Manufacturing (CMC) · Supplement 22 · standardAP
2014-08-29Manufacturing (CMC) · Supplement 26 · standardAP
2009-11-02Labeling · Supplement 19 · standard — Letter ↗AP
2004-01-23Labeling · Supplement 13 · standard — Letter ↗AP
2003-05-21Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2002-07-25Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2002-07-25Labeling · Supplement 11 · standard — Letter ↗AP
2002-02-15Manufacturing (CMC) · Supplement 9 · standardAP
2001-04-04Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-19Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-12Efficacy · Supplement 3 · standard — Letter ↗AP
2000-03-24Manufacturing (CMC) · Supplement 5 · standardAP
2000-02-25Manufacturing (CMC) · Supplement 4 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 2 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-29Type 4 - New Combination · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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