Home Applications 018582 Application 018582
Type NDA
Sponsor B BRAUN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROCALAMINE AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018582-001 PROCALAMINE AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION 1982-05-08
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.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N018582-001 PROCALAMINE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION 1982-05-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018582-001 PROCALAMINE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION 1982-05-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018582-001 PROCALAMINE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION 1982-05-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018582-001 PROCALAMINE 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML INJECTABLE / INJECTION 1982-05-08 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0264-1915 ProcalAmine GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE B. Braun Medical Inc. NDA Current 0264-1915 ProcalAmine GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE B. Braun Medical Inc. NDA Current 0264-1915 ProcalAmine GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE B. Braun Medical Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33507 SUPPL 2004-01-15 951 SUPPL 2004-01-09