Composition
- Active ingredients
- TADALAFIL 5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- TADALAFIL 20MG · TabletNDA021368-003 · Prescription
- TADALAFIL 5MG · TabletThis page
- TADALAFIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021368-004 · Discontinued
- TADALAFIL 10MG · TabletNDA021368-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021368.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Cialis
- Active substance
- tadalafil
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Lilly
- Status
- Prescription
- FDA approval
- 21 Nov 2003
- Application
- NDA021368-001