NDA vs ANDA: How New and Generic Drugs Are Approved
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NDA vs ANDA

Also called New Drug Application, Abbreviated New Drug Application, NDA, ANDA, drug approval pathway · Reviewed

Definition: A New Drug Application (NDA) is how a company formally asks the FDA to approve a new drug for sale in the US. An Abbreviated New Drug Application (ANDA) is how a company asks to sell a generic version. The FDA says the ANDA is abbreviated because it generally does not need new animal or human trial data.

The two side by side

From the FDA pages on NDAs and ANDAs
NDAANDA
ForA new drugA generic version of an approved drug
DataAnimal studies and human clinical trials, what the drug is made of, how it acts in the body, and how it is made and packagedGenerally no new animal or human data on safety and effectiveness
Main questionIs the drug safe and effective for its proposed use, do benefits outweigh risks, is the label right, and is manufacturing adequateDoes it perform like the brand drug: the same amount of active ingredient into the bloodstream in the same time (bioequivalence)

The FDA lists approved brand and generic products in Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book.

What neither covers

Compounded drugs are not approved through either application; see 503A vs 503B. Biologic copies follow a different path; see biosimilar.

Why it matters for your log

A switch from a brand to a generic, or between generics, is still a change of product. Log the product name and maker so your history shows when it happened.

Read more on Dose Track: Compounded vs brand semaglutide · Metformin side effects · Glimepiride vs glipizide

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
Generic drugA generic drug is an FDA-approved copy of a brand-name drug. FDA requires it to have the same active… BiosimilarA biosimilar is a biologic medicine that is highly similar to a biologic FDA has already approved, called… 503A vs 503B503A and 503B are two sections of US drug law that set the rules for compounding. A 503A pharmacy… Clinical trial phasesClinical trial phases are the steps a drug goes through in human testing. The FDA describes four: phase 1… Prescribing informationPrescribing information is the FDA-approved label for a prescription drug, written mainly for health care…

Frequently asked questions

Why is a generic application called abbreviated?+
The FDA says generic applications are generally not required to include animal and human data to show safety and effectiveness. They show bioequivalence to the brand drug instead.
What is the Orange Book?+
It is the FDA list of approved drug products, brand and generic, formally called Approved Drug Products with Therapeutic Equivalence Evaluations.

Sources

  1. FDA: New Drug Application (NDA)
  2. FDA: Abbreviated New Drug Application (ANDA)

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