Application Nr Approved Date Route Status External Links
NDA020727 2005-06-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bidil Is 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 (1.1) Limitations Of Use: There Is Little Experience In Patients With Nyha Class Iv Heart Failure (1.2) 1.1 Treatment Of Heart Failure In Self-Identified Black Patients Bidil Is Indicated For The Treatment Of Heart Failure As An Adjunct To Standard Therapy In Self-Identified Black Patients To Improve Survival, To Prolong Time To Hospitalization For Heart Failure, And To Improve Patient-Reported Functional Status. 1.2 Limitations Of Use There Is Little Experience In Patients With Nyha Class Iv Heart Failure.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 2 Total)

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