• Active Ingredient-Active Moiety Validation Procedures
  • Combination Product Type Validation Methods
  • DEA Schedule Controlled Substance List
  • SPL Validation Files for DEA Schedule
  • SPL Validation Files for DEA Schedule

Keywords

  • SPL
  • Drug Dictionary
  • Pharmaceutical Dictionary
  • Drug Labels
  • Active Ingredient
  • Drug Enforcement Administration
  • DEA
  • OTC Drugs
  • Drug Monograph List
  • Vaccines Antigen Validation

FDA Drug Product Labels Validation Method Data Package

$1,074 $750 / YEAR

This data package contains information on Structured Product Labeling (SPL) Terminology for SPL validation procedures and information on performing SPL validations.

Benefits
- Helps in gathering product and facility information - Information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type) of FDA approved drugs can be obtained through this dataset. - The "drug label" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug.
INCLUDED DATASETS (6)
1. Active Ingredient Active Moiety Relationship Validation Procedure ($179)
2. Controlled Substances Schedule ($179)
3. DEA Controlled Substance Validation Procedure ($179)
4. DEA Exempted Substance Validation Procedure ($179)
5. Structured Product Labeling Validation Procedures ($179)
6. Vaccine Antigen Substance Validation Procedure ($179)



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