Drug Application File

In July 2007, the Centers for Medicare and Medicaid Services (CMS) declared that the presence of an Abbreviated New Drug Application would be used for determining generic status and copayments within Medicare Part D prescription drug programs. The Drug Application File was created for use by healthcare organizations involved in the processing of Medicare Part D prescriptions. By providing the FDA-based data as a part of a customer’s regular file delivery, Medi-Span shields our customers from layout changes and non-routine postings by the government; simplifying maintenance of this data set.

FEATURES

• The Drug Application File provides:
• FDA Application Number
• Application Type (NDA, ANDA, BLA)
• FDA Approval Date
• FDA’s Therapeutic Equivalence
• Reference Listed Drug Status
• Product Number
• Indicator flag that identifies an NDC as being available in the Medi-Span® drug files
• Medi-Span inactive date tor NDC’s present in the Medi-Span drug file, but inactive
• Manufacturer-reported information in advance of the FDA’s website postings
• Files are automatically updated when revisions are posted to the FDA website

BENEFITS

FOR PAYERS

• Saves time by eliminating the need to monitor the FDA website for drug status
• Raises awareness by providing new application approval information prior to FDA website posting
• Click here to download the PDF

FOR PHARMACISTS

• Saves time by eliminating the need to monitor the FDA website for drug status
• Raises awareness by providing new application approval information prior to FDA website posting
• Click here to download the PDF

This product is produced and delivered to customers on a daily, weekly or monthly basis.