Quick answers
- What is Fosamprenavir calcium used for?
- The FDA-approved label (Fosamprenavir Calcium, Sun Pharmaceutical Industries, Inc., June 30, 2026) says: “Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fosamprenavir calcium have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fosamprenavir calcium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fosamprenavir calcium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fosamprenavir calcium?
- 2 companies list prescription products of Fosamprenavir calcium in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc. and Mylan Pharmaceuticals Inc..
What Fosamprenavir calcium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients …
— FDA label: Fosamprenavir Calcium, Sun Pharmaceutical Industries, Inc., effective June 30, 2026. Read the full label on DailyMed →
The FDA has 2 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.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, coated · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
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.
- Sun Pharmaceutical Industries, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA204060Mylan · April 15, 2016
- ANDA204024Sun Pharm · November 20, 2019
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) | 402109 |
|---|---|
| SPL set ID of the quoted label | 5cd1eead-9fc1-426c-bee8-214ffa7d9dc1 |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | FOSAMPRENAVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fosamprenavir Calcium, Sun Pharmaceutical Industries, Inc., effective June 30, 2026; 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 →