PPT ON ANDA (Nagori Stavan ArunkumarDepartment of PharmaceuticsL.M.College of Pharamcy)
- Introduction
- History of ANDA
- Guidelines available for ANDA
- Filling of ANDA
- Manufacturing and control requirements of the ANDA
- 180 days exclusitivity under Hatch Waxman amendment
- Concept of Paragraph I to IV
- Substantially complete ANDA
- House keeping regulation
- Patent expiration regulation
- Triggering period
- Waivers of exclusitivity
- 505(b)(2) application
- Supplemental new drug applications
- Case studies
- List of ANDA approved
- 2006 pending ANDA
- ANDA filed by or with Indian Pharmaceutical company
- List of references
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