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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. Thirty-eight 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: | 1 |
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 | 0002-4462 | 0002-4462-34 | 2 BLISTER PACK in 1 CARTON (0002-4462-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4462-79) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 21, 2003 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 15, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Feb 15, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Oct 26, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 021368
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | Start Trial | Start Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | Start Trial | Start Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | Start Trial | Start Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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