Treats heart failure. NDA 20727, held by Azurity. Hydralazine Hydrochloride; Isosorbide Dinitrate.
As of Nov 13, 2026, NDA 20727 (Bidil), held by Azurity, was first approved by FDA on Jun 23, 2005, with 5 approved supplements and 0 published complete response letters.
Isosorbide dinitrate and hydralazine hydrochloride tablets are a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status Limitations of use: There is little experience in patients with NYHA class IV heart failure 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2005 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bidil37.5MG;20MG · tablet;oral | Hydralazine Hydrochloride; Isosorbide Dinitrate | RxReference drug |
| Jan 13, 2021 | Supplement 12Manufacturing | Approved | |
| Mar 12, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Jun 14, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 2, 2015 | Supplement 5Labeling · Standard review | Approved | |
| Mar 27, 2013 | Supplement 4Labeling | Approved | |
| Jun 23, 2005 | Original applicationNew combination · Standard review | 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
