Quick answers
- What is Efavirenz, lamivudine and tenofovir disoproxil fumarate used for?
- The FDA-approved label (Symfi, Viatris Specialty LLC, October 15, 2019) says: “SYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Efavirenz, lamivudine and tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Symfi has a boxed warning (“WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Efavirenz, lamivudine and tenofovir disoproxil fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Efavirenz, lamivudine and tenofovir disoproxil fumarate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Efavirenz, lamivudine and tenofovir disoproxil fumarate?
- 2 companies list prescription products of Efavirenz, lamivudine and tenofovir disoproxil fumarate in the FDA NDC Directory, including Laurus Labs Limited and Viatris Specialty LLC.
What Efavirenz, lamivudine and tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. …
— FDA label: Symfi, Viatris Specialty LLC, effective October 15, 2019. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B
. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Symfi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Laurus Labs Limited2 products
- Viatris Specialty LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022142 SYMFI | Mylan Labs Ltd | March 22, 2018 | 1, latest October 29, 2019 2019: Labeling |
Generic approvals (2)
- ANDA212786Laurus · May 14, 2020
- ANDA213038Laurus · May 14, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 864661, 2001424, 2043464 |
|---|---|
| SPL set ID of the quoted label | 81a55dd9-78a8-49c3-88ab-8f5bffafa359 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA022142, 2 ANDA |
| Active ingredients (FDA) | EFAVIRENZ / LAMIVUDINE / TENOFOVIR DISOPROXIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Symfi, Viatris Specialty LLC, effective October 15, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →