Application 020734

Type: NDA
Sponsor: BAXTER HLTHCARE

Related Records

Company: BAXTER HLTHCARE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;5GM/100ML	No	No
002	CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;10GM/100ML	No	No
005	CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	2.75%;25GM/100ML	No	No
007	CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;5GM/100ML	No	No
008	CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;10GM/100ML	No	No
010	CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;20GM/100ML	No	No
011	CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	4.25%;25GM/100ML	No	No
014	CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;10GM/100ML	No	No
015	CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;15GM/100ML	No	No
016	CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;20GM/100ML	No	No
017	CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;25GM/100ML	No	No
018	CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	5%;35GM/100ML	No	No
019	CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE	INJECTABLE;INJECTION	8%;14GM/100ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0180	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0180	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0180	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0180	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0184	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0184	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0184	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0184	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0188	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0188	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0188	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0188	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0194	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0194	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0194	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0194	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0198	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0198	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0198	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-0198	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1089	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1089	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1089	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1089	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1089	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1091	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1091	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1091	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1091	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1091	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1099	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1099	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1099	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1099	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1099	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1101	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1101	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1101	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1101	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1101	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1133	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1133	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1133	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1133	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1133	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1134	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1134	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1134	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1134	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1134	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1136	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1137	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1137	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1137	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1137	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1137	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1138	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1138	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1138	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1138	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1138	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current
0338-1139	CLINIMIX	Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose	Baxter Healthcare Corporation	NDA	Current

Documents

Document	Submission type	Date
67072	SUPPL	2021-04-16
67058	SUPPL	2021-04-14
55908	SUPPL	2018-10-15
45570	SUPPL	2016-10-21
45569	SUPPL	2016-10-21
3233	SUPPL	2010-01-20
3232	SUPPL	2004-02-02
3231	SUPPL	2003-06-08
25659	SUPPL	2002-07-25
3230	SUPPL	2002-07-25
3229	SUPPL	2000-04-12