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Where to Find the Document
The Approved Drug Products with Therapeutic Equivalence Evaluations (ADETE) is a public‑domain resource published by the U.S. Department of Health & Human Services (HHS) and the Food and Drug Administration (FDA). The 38th Edition (2018) is available for download from the FDA’s “Drug Products” portal:
1. FDA Drug Products Website
- Visit the FDA’s Drug Products page: https://www.fda.gov/drugs/drug-safety-and-availability/drug-products
- Scroll to the “Drug Product Code (DRUGCODE)” or “Approved Drug Products with Therapeutic Equivalence Evaluations” section.
- Click the PDF link for the 2018 38th‑edition file. The file size is typically ~30 MB and contains a single PDF.
2. Direct URL (if you’re looking for a quick link)
- https://www.fda.gov/media/107771/download
(Note: links may change; use the search bar on the FDA site if the above link no longer works.)
What the 38th Edition Contains
The ADETE is a structured table that lists every FDA‑approved drug product that has been evaluated for therapeutic equivalence. Each entry includes:
| Field | Typical Content |
|-------|-----------------|
| Drug Product Name | e.g., “Aspirin 325 mg Tablet” |
| Manufacturer | e.g., “Bayer HealthCare” |
| Drug Product Code (DRUGCODE) | 8‑digit numeric code (e.g., 00412345) |
| NDC (National Drug Code) | 10‑digit retail code (e.g., 12345‑6789‑01) |
| Therapeutic Equivalence Class | Letter code (e.g., TEB, TEE, TEG, TEJ) indicating the class of therapeutic equivalence |
| Therapeutic Equivalence Evaluation | Brief statement, such as “This drug product is therapeutically equivalent to the reference listed drug (RLD) in the same class.” |
| Date of Evaluation | e.g., 2017‑12‑31 |
Therapeutic Equivalence Class Codes (Examples)
| Code | Description |
|------|-------------|
| TEA | Drug product has an approved drug product code and has been evaluated for therapeutic equivalence. |
| TEB | Drug product has an approved drug product code and has been evaluated for therapeutic equivalence to a reference listed drug. |
| TEE | Drug product is a generic and has been evaluated for therapeutic equivalence to an approved brand. |
| TEG | Drug product is a generic but has not yet received a therapeutic equivalence class (pending evaluation). |
| TEJ | Drug product is a brand or specialty product with a unique therapeutic equivalence class. |
Typical Uses of the ADETE
- Pharmacy Benefit Managers (PBMs) and insurers use it to determine which generic drugs can be substituted for brand products.
- Pharmacists refer to the ADETE during medication reconciliation and substitution decisions.
- Regulatory professionals consult it for drug‑labeling and compliance audits.
How to Use the Information
1. Identify the drug product you’re interested in by searching the table for its name or NDC.
2. Check the therapeutic equivalence class:
- If it’s TEB, TEE, or TEF, the product can usually be substituted for the reference listed drug.
- If it’s TEG or TEJ, substitution may not be permissible without additional review.
3. Verify the date of evaluation to ensure the data are up to date (the 38th edition reflects evaluations up to December 2018).
Sample Entry (Hypothetical)
| Drug | Manufacturer | DRUGCODE | NDC | TE Class | Evaluation |
|------|--------------|----------|-----|----------|------------|
| Metformin HCl 500 mg Tablet | Eli Lilly & Co. | 00123456 | 12345‑6789‑01 | TEB | “This product is therapeutically equivalent to the reference listed drug, Metformin HCl 500 mg Tablet (RLD).” |
(The above is illustrative; actual entries will include the real manufacturer names, NDCs, and evaluation text.)
If You’re Having Trouble Locating the File
- Try the FDA’s “Drug Product Code” (DRUGCODE) database: https://www.fda.gov/drugs/drug-safety-and-availability/drug-product-code-database.
- Use the search function for “therapeutic equivalence evaluations” and filter by publication year (2018).
- If you’re on a Windows machine, the path you mentioned (C:\Users\Vhawla\2\AppData\Local\Temp\4\MicrosoftEdge\Downloads) indicates the file may have been downloaded to your temporary folder; you can open that folder directly or copy the PDF to a more permanent location.
Key Takeaway
The 38th Edition (2018) ADETE is a comprehensive, FDA‑published table of drug products with their therapeutic equivalence evaluations. It’s freely available on the FDA website and is invaluable for pharmacists, insurers, and regulatory professionals when determining drug substitution and compliance. If you need a specific entry or want to confirm a drug’s therapeutic equivalence class, consult the PDF or use the FDA’s searchable database.