Application 020849

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERAMINO ACIDSINJECTABLE;INJECTION20% (20GM/100ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent
0338-0499ProSolValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and TyrosineBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64715SUPPL2020-09-29
64664SUPPL2020-09-24
56202SUPPL2018-10-31
56189SUPPL2018-10-30
21020ORIG2005-07-11
26051SUPPL2003-05-30
3572SUPPL2003-05-29
26050ORIG1998-08-26
13612ORIG1998-08-26