Treats human immunodeficiency virus (HIV-1) infection. ANDA 204060, held by Mylan. Fosamprenavir Calcium.
As of Nov 15, 2026, ANDA 204060 (Fosamprenavir Calcium), held by Mylan, was first approved by FDA on Apr 15, 2016, with 2 approved supplements and 0 published complete response letters.
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 plus ritonavir in protease inhibitor-experienced patients:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosamprenavir CalciumEQ 700MG BASE · tablet;oral | Fosamprenavir Calcium | Rx |
| Mar 19, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 19, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 15, 2016 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
