tadalafil
tadalafil is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including TADALAFIL, tadalafil, Tadalafil. Available dosage forms: tablet, tablet, film coated, tablet, coated, powder.
Drug Details
- Generic Name
- tadalafil
- Brand Names
- TADALAFIL, tadalafil, Tadalafil
- Application Number
- ANDA210609
- Sponsor
- Solco Healthcare US, LLC
- NDC Codes
- 50
- Dosage Forms
- TABLET, TABLET, FILM COATED, TABLET, COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- TADALAFIL
Indications and Usage
1 INDICATIONS AND USAGE Tadalafil Tablets are 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 Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Tadalafil Tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of Tadalafil Tablets beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .