FDA.reportPublic FDA data

Application 020512

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINERAMINO ACIDSINJECTABLE;INJECTION15% (15GM/100ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A020512-001CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINERAMINO ACIDS15% (15GM/100ML)INJECTABLE / INJECTION1996-08-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A020512-001CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER15% (15GM/100ML)INJECTABLE / INJECTION1996-08-30a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClinisolLYSINE, LEUCINE, PHENYLALANINE, VALINE, HISTIDINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, TYROSINEBaxter Healthcare Corporation65ffc962-7538-41ea-9afb-4af5fbce4c5b2018-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 020512
application number: ANDA020512
ndc (product): 0338-0502

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0502ClinisolLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, TyrosineBaxter Healthcare CorporationANDACurrent
0338-0502ClinisolLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, TyrosineBaxter Healthcare CorporationANDACurrent
0338-0502ClinisolLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, TyrosineBaxter Healthcare CorporationANDACurrent
0338-0502ClinisolLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, TyrosineBaxter Healthcare CorporationANDACurrent
0338-0502ClinisolLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, TyrosineBaxter Healthcare CorporationANDACurrent