ANDA 206002, held by Alvogen Pine Brook. Bosentan.
As of Nov 14, 2026, ANDA 206002 (Bosentan), held by Alvogen Pine Brook, was first approved by FDA on Apr 26, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2019 | Original application | Approved | None posted |
| Apr 29, 2022 | Supplement 3REMS | Approved | None posted |
| Apr 26, 2019 | Original application | Approved | None posted |
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
