Quick answers
- What is Lamivudine and tenofovir disoproxil fumarate used for?
- The FDA-approved label (Cimduo, Viatris Specialty LLC, February 15, 2021) says: “CIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lamivudine and tenofovir disoproxil fumarate have a boxed warning?
- Yes. The FDA label for Cimduo 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 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 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 Lamivudine and tenofovir disoproxil fumarate?
- 1 company lists prescription products of Lamivudine and tenofovir disoproxil fumarate in the FDA NDC Directory, including Viatris Specialty LLC.
What Lamivudine and tenofovir disoproxil fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. …
— FDA label: Cimduo, Viatris Specialty LLC, effective February 15, 2021. Read the full label on DailyMed →
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 →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cimduo |
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.
- Viatris Specialty LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022141 CIMDUO | Mylan Labs Ltd | February 28, 2018 | 1, latest July 10, 2018 2018: UNKNOWN |
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) | 2003249, 2003255 |
|---|---|
| SPL set ID of the quoted label | a300f04d-118f-4136-aaf3-ddfd00197f86 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA022141 |
| Active ingredients (FDA) | LAMIVUDINE / TENOFOVIR DISOPROXIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cimduo, Viatris Specialty LLC, effective February 15, 2021; 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 →