Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090141

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TADALAFIL (TADALAFIL)
2.5MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: TADALAFIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A090141
Product Number: 001
Approval Date: May 22, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

TADALAFIL (TADALAFIL)
5MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: TADALAFIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A090141
Product Number: 002
Approval Date: May 22, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

TADALAFIL (TADALAFIL)
10MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: TADALAFIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A090141
Product Number: 003
Approval Date: May 22, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

TADALAFIL (TADALAFIL)
20MG
Marketing Status: Prescription

Active Ingredient: TADALAFIL
Proprietary Name: TADALAFIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A090141
Product Number: 004
Approval Date: May 22, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information