Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021368

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CIALIS (TADALAFIL)
2.5MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: CIALIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021368
Product Number: 004
Approval Date: Jan 7, 2008
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CIALIS (TADALAFIL)
5MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: CIALIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021368
Product Number: 001
Approval Date: Nov 21, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CIALIS (TADALAFIL)
10MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: CIALIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021368
Product Number: 002
Approval Date: Nov 21, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CIALIS (TADALAFIL)
20MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: CIALIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N021368
Product Number: 003
Approval Date: Nov 21, 2003
Applicant Holder Full Name: ELI LILLY AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information