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Animal NDC 86251-001-01 Celtic Polled Cattle

Celtic Polled Alteration On Bovine Autosomal Chromosome 1

Animal Product Information

Field Name Field Value
Animal NDC Code 86251-001-01
Proprietary Name Celtic Polled Cattle What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Celtic Polled Alteration On Bovine Autosomal Chromosome 1 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Acceligen
Product Type Intentional Animal Genomic Alteration
Usage Information
    Product Use: Founder animals are intended for production and sale of semen to enable the establishment of polled herds, the progeny of which will be used as a food source.
Active Ingredient(s)
  • Bos Taurus G.(nc_037328.1) Dup(2429109-2429320) + Del(2429327-2429336)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Celtic Polled Cattle Images

Celtic Polled Cattle Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Statement Of Identity



Identity: CRISPR-Cas12a editing with homology dependent repair in cattle to introduce two copies of the Celtic allele of Bos taurus chromosome 1 (NC_037328.1). The intended mutations resulted in presence of a known polled genotype variation already present within the species.


Health Claim



Claim: The homozygous Celtic allele will allow the introduction of a polled phenotype into horned cattle.


Indications & Usage



Product Use: Founder animals are intended for production and sale of semen to enable the establishment of polled herds, the progeny of which will be used as a food source.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.