Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug Application (ANDA).

Obtaining marketing approval for a generic drug requires good data as well as a clear understanding of the regulatory milestones that need to be met and when they need to happen. Without both aspects, your generic drug application has little chance of remaining on schedule.

Most ANDA applications are rejected by the FDA on the first pass through the Agency, resulting in loss of both time and money. For many reasons, it pays to get your product approved as quickly as possible. How can you do that? The help of an experienced and reputable consultant is a great place to start.

Are you curious about any of the following:

  • How is an ANDA different from an NDA?
  • How to determine if your product needs a 505(j) or a 505(b)(2)?
  • What are the FDA's stability requirements?
  • How can ProPharma Group help you through the generic drug process?

The answers to these questions, plus a step-by-step guide through the entire approval process, are all covered in our overview. Download the infographic today to learn how to successfully navigate the FDA's generic drug approval process.




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