Instant Report
FDF

FDA (FOOD AND DRUG ADMINISTRATION) ORANGE BOOK:

The publication approved drug products with therapeutic Equivalence evaluation named as Orange Book based on drug product approved by Food and Drug Administration (FDA). It included only currently marketed prescription drug products approved by FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the FD&C Act and FDA regulations at that time. In FDA Orange book listed drug must be safe and must be prove effective. It also includes therapeutic equivalence evaluation for approved multisource prescription drug product. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the domain of drug.

Key Highlights

Countries

200


Molecules

25000


Downloadable Report

Quick-Report

Instant access to global buyers info with their contacts for a specific product(s) in an excel sheet


Contact details

Finished Dosage Form (FDF) Listed Buyers Key & decision maker(s) of all buyers including name, number and email address

Verified data points

We ensure highest level of correctness & consistency of data points and contact details

Data Coverage

BASIC INFO     BASIC INFO

  • Basic Information
  • Innovator
  • Developer
  • Indication
  • Market Status
  • Segment
  • Approval Year

APPLICATION     APPLICATION

  • Industry Application
  • End Application

COMMERCIAL INFO     COMMERCIAL INFO

  • Global Manufacturer / Buyer
  • Country Covered
  • Buying Volume (MT)
  • Supplying Volume (MT)
  • Global Market Size AI
  • Average Price ($) AI
  • US Drug Sales (M USD)FDF

TECHNICAL INFO     TECHNICAL INFO

  • Route Of Synthesis
  • Technology
  • Mechanism of Action

REGULATORY INFO     REGULATORY INFO

Active Ingredient

  • USDMF
  • JDMF
  • KDMF
  • CEP/COS
  • EU API Registered
  • India EU Written Confirm
  • India Import Licence
  • REACH Registration

Formulation

  • ANDA
  • Canada Registered
  • Australia Registered
  • Europe Registered
  • South Africa Registered
  • India Registered
  • Brazil Registered
  • Japan Registered
  • India Registered Pesticide
  • EU Registered Pesticide
  • US Veterinary Registered
  • EU Veterinary Registered
  • US Excipient Registered

CLINICAL TRIAL     CLINICAL TRIAL

  • Clinical Trial (US)
  • Clinical Trial (EU)
  • Clinical Trial (Japan)
  • Clinical Trial (India)
  • Clinical Trial (NZ and AU)
  • Clinical Trial (Canada)
PATENT

PATENT

  • Patent Expiry
  • Exclusivity
  • SPC
  • Para IV
CERTIFICATION

CERTIFICATION

  • Buyer Certification
  • Supplier Certification
  • EU GMP Certified Site
  • USFDA Certified Site
  • CDSCO Certified Site
ALERT/WARNING

ALERT/WARNING

  • Recall/Withdrawal (USFDA)
  • Warning (USFDA)
  • Site Inspection (USFDA)
  • Banned Drug India (CDSCO)
  • Banned Pesticide (India)
  • Banned Pesticide (World)