How do I know if a medication is FDA approved?

October 9, 2025 •

3 min read

According to the U.S. Food and Drug Administration (FDA), a robust, multi-stage evaluation process is required before a new drug can be approved for sale. Knowing how to know if a medication is FDA approved is a critical step for patients and consumers to ensure the safety and effectiveness of the products they use.

Quick Summary

Verifying FDA approval involves using official FDA databases such as Drugs@FDA, the Orange Book for small-molecule drugs, and the Purple Book for biologics.

Key Points

Use FDA Databases: The official Drugs@FDA website is the most reliable place to search for FDA-approved prescription, generic, and some OTC drugs.
Check for Application Numbers: FDA-approved prescription and generic drugs have specific application numbers (NDA, ANDA). Searching by this number can confirm approval.
Differentiate Drug Types: Not all medications require individual FDA approval; many OTC drugs follow a specific monograph, and dietary supplements are not FDA-approved.
Consult the Orange and Purple Books: Use the Orange Book for small-molecule generics and the Purple Book for therapeutic biologics like biosimilars.
Beware of Unverified Claims: Be skeptical of products, especially dietary supplements, advertised as “FDA approved,” and always verify claims through official channels.
Consult a Professional: When in doubt, speak to a pharmacist or doctor to verify a medication's approval status and safety.

FDA approval is the gold standard for drug safety and effectiveness in the United States, signifying that a product has undergone rigorous testing and review to ensure its benefits outweigh its risks. For consumers, verifying a medication's approval status offers reassurance and protection against potentially harmful or ineffective products. The FDA offers several public databases to help confirm a drug's regulatory standing.

Primary FDA Databases for Verification

The most dependable way to check a medication's approval status is by using the FDA's official online databases, which are regularly updated.

Drugs@FDA

Drugs@FDA is a searchable catalog that includes most FDA-approved human drugs since 1939, covering prescription, generic, and many over-the-counter (OTC) medications. Users can find drug labels, approval letters, review documents for many products, and information on various drug types. To use it, visit the Drugs@FDA website and search by drug name, active ingredient, or application number. Search results provide detailed information, including approval history and official labeling.

The Orange Book

Officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is primarily for small-molecule drugs. It lists approved drug products and their therapeutic equivalence ratings, which is particularly useful for finding approved generic alternatives to brand-name prescription drugs.

The Purple Book

For biological products like vaccines and gene therapies, the FDA provides the Purple Book. It includes information on licensed biological products, including biosimilars and interchangeable products, and is searchable by brand or proper name. It can be accessed on the FDA website.

Differentiating Regulatory Pathways

The regulatory pathway for medications varies by product type.

Prescription and New Over-the-Counter (OTC) Drugs

New prescription and certain OTC drugs require a New Drug Application (NDA), involving preclinical studies and clinical trials to prove safety and effectiveness.

OTC Monograph Drugs

Many common OTC drugs are regulated under an OTC Drug Monograph, a set of rules for specific drug classes deemed generally recognized as safe and effective (GRASE). Products conforming to a monograph can be marketed without formal premarket approval.

Dietary Supplements

Dietary supplements are not FDA-approved before marketing. Manufacturers are responsible for safety and truthful claims, and the FDA acts only if a product is found unsafe after it is on the market.

Understanding FDA Approvals and Application Numbers

FDA-approved prescription drugs are assigned unique application numbers:

New Drug Application (NDA): For brand-name prescription drugs.
Abbreviated New Drug Application (ANDA): For generic drug products.
Biologics License Application (BLA): For therapeutic biological products.

Comparison of Key FDA Databases


Feature	Drugs@FDA	Orange Book	Purple Book
Primary Purpose	Comprehensive database of approved human drugs and biologics.	Lists approved small-molecule drugs and their therapeutic equivalents.	For licensed biological products like biosimilars and interchangeable products.
Product Types	Prescription (brand/generic), many OTC drugs, therapeutic biologics.	Prescription and OTC small-molecule drugs.	Therapeutic biological products (e.g., vaccines, monoclonal antibodies).
Search Capabilities	Search by drug name, active ingredient, or application number.	Search by active ingredient, proprietary name, or applicant.	Searchable by name {Link: FDA Purple Book https://purplebooksearch.fda.gov/}.
Key Information	Labeling, approval history, reviews.	Therapeutic equivalence codes for generics.	Biosimilarity or interchangeability evaluations.

What to Do If You Encounter an Unapproved Medication

If a product claims FDA approval but cannot be verified through official channels, proceed with caution. Unapproved drugs are not evaluated for safety, effectiveness, or quality and may be counterfeit, contaminated, or contain incorrect ingredients. Consult a healthcare provider or pharmacist if you have concerns and consider reporting the product to the FDA via the MedWatch program.

Conclusion

Checking a medication's FDA approval is a simple yet crucial step for making informed health decisions. Utilizing official FDA databases like Drugs@FDA, the Orange Book, and the Purple Book allows quick verification that a drug meets safety and effectiveness standards. While other sources exist, the FDA's website is the most authoritative. Always consult a healthcare professional for any uncertainties.

Additional Resources

For more information on the FDA's drug approval process and databases, visit the FDA's official website at www.fda.gov.

Frequently Asked Questions

The easiest way is to use the Drugs@FDA online database. You can search for the drug by its brand name, generic name, active ingredient, or application number to find its approval status and details.

Many OTC drugs do not require individual FDA approval if they meet the conditions of an established OTC monograph, which means they are 'generally recognized as safe and effective' (GRASE). You can check the FDA website for information on the relevant monograph.

No, the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. Manufacturers are responsible for ensuring the safety and truthfulness of claims.

Taking unapproved medication carries significant risks, as these products may be ineffective, contaminated, or contain incorrect or dangerous ingredients. They have not been rigorously tested for safety.

The Orange Book lists FDA-approved small-molecule drugs and their therapeutic equivalence information. The Purple Book is a database for licensed biological products, including biosimilars and interchangeable products.

You can check a generic drug's approval by looking it up in the Drugs@FDA database or the Orange Book. Generic drugs have an Abbreviated New Drug Application (ANDA) number.

An FDA application number (NDA, ANDA, or BLA) is a unique identifier assigned during the approval process. You can search for this number in the Drugs@FDA database to get direct information on that specific product's approval.