Treats only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection. ANDA 203347, held by Hetero Labs Ltd Iii. Maraviroc.
As of Nov 15, 2026, ANDA 203347 (Maraviroc), held by Hetero Labs Ltd Iii, was first approved by FDA on Feb 7, 2022, with 0 approved supplements and 0 published complete response letters.
Maraviroc tablets are indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2022 | 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
