Information about an Application includes:
Application Type (NDA, ANDA, BLA)
Application Number
Links to Patient Information (Medication Guide,patient package inserts)
Product(s) on the application:
drug name
active ingredient
dosage form and route of administration
strength
product marketing status (prescription, over-the-counter, or discontinued)
company that sponsored an application for approval
Links to Letters, Labels, Reviews, if available in electronic form
Therapeutic Equivalents for prescription drugs
For over-the-counter drugs, other OTC drugs with the same active ingredient, strength and dosage form/route
Approval History
For Original Approvals
Submission Type (formerly called “chemical type”) for NDAs
Review Priority for NDAs
For Supplements
Submission Type
Approval Date
