Treats HIV-1 infection. ANDA 204587, held by Hetero Labs Ltd Iii. Ritonavir.
As of Nov 15, 2026, ANDA 204587 (Ritonavir), held by Hetero Labs Ltd Iii, was first approved by FDA on Sep 17, 2018, with 0 approved supplements and 0 published complete response letters.
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ritonavir100MG · tablet;oral | Ritonavir | Rx |
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
