Application Nr Approved Date Route Status External Links
NDA021368 2008-01-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage CialisĀ® Is A Phosphodiesterase 5 (pde5) Inhibitor Indicated For The Treatment Of: Erectile Dysfunction (ed) (1.1) The Signs And Symptoms Of Benign Prostatic Hyperplasia (bph) (1.2) Ed And The Signs And Symptoms Of Bph (ed/bph) (1.3) If Cialis Is Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks (1.4). 1.1 Erectile Dysfunction CialisĀ® Is Indicated For The Treatment Of Erectile Dysfunction (ed). 1.2 Benign Prostatic Hyperplasia Cialis Is Indicated For The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (bph). 1.3 Erectile Dysfunction And Benign Prostatic Hyperplasia Cialis Is Indicated For The Treatment Of Ed And The Signs And Symptoms Of Bph (ed/bph). 1.4 Limitation Of Use If Cialis Is Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks Because The Incremental Benefit Of Cialis Decreases From 4 Weeks Until 26 Weeks, And The Incremental Benefit Of Cialis Beyond 26 Weeks Is Unknown [see Clinical Studies (14.3)].

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tadalafil TADALAFIL ZINC3993855

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