Details for New Drug Application (NDA): 021368
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The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 021368
Tradename: | CIALIS |
Applicant: | Lilly |
Ingredient: | tadalafil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021368
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 021368
Suppliers and Packaging for NDA: 021368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4462 | 0002-4462-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30) |
CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4463 | 0002-4463-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 21, 2003 | TE: | AB1 | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 21, 2003 | TE: | AB1 | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 21, 2003 | TE: | AB1 | RLD: | Yes |
Expired US Patents for NDA 021368
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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