In order to view the video portion of this training, the following are required:
If you are unable to meet the above requirements, you also have the following options:
After completing the training, please reference the following links for more resources:
For more information, please consult our Technical Support section.
Key Points
Audio Transcript
We are going to start by asking, "Is the active ingredient in an approved NDA or ANDA listed in the Orange Book?" Remember, the Orange Book lists all approved NDAs or ANDAs and is updated monthly. ANDAs, however, are updated daily.
If the active ingredient does NOT have an approved NDA or ANDA listed in the Orange Book then, following the decision tree, you would need to see if it is under the OTC Drug Review System. We will address the OTC Drug Review System later.
If the active ingredient DOES have an NDA or ANDA listed in the Orange Book, you will need to determine if there is anything different (for example, indication, strength, dosage form, route of administration) about your product.
If there is NOT anything different with your product, then you should seek to have the product approved through the ANDA process.