, 2 Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection. NETSPOT is a Kit with the following components: 1 Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline 6 mcg gentisic acid 20 mg mannitol. (D)-Phenylalanyl-(L)Cysteinyl-(L)-Tyrosyl-(D)-Tryptophanyl-(L)-Lysyl-(L)-Threoninyl-(L)-Cysteinyl-(L)-Threonine-cyclic(2-7)disulfide. Dotatate has a molecular weight of 1435.6 Daltons and its chemical structure is shown in Figure 3. The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-Thr-Cys-Thr-OH, and contains one disulfide bond. Dotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). NETSPOT is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use.
Therefore, all products having "unfinished" status are considered unapproved. Including the marketing categories of Active Pharmaceutical Ingredient (API),ĭrug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding.įDA does not review and approve unfinished products. Unfinished (Unapproved) The following status describes submitted unfinished drugs,.
Uses of medication netspot code#
Name of Company corresponding to the labeler code segment of the ProductNDC. The complete list of codes and translations can be found at under Structured Product Labeling Resources.Īdvanced Accelerator Applications USA, Inc
This data element corresponds to the “Document Type” of the SPL submission for the listing. Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. Sometimes called the generic name, this is usually the active ingredient(s) of the product.
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