Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216383

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SILDENAFIL CITRATE (SILDENAFIL CITRATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: SILDENAFIL CITRATE
Proprietary Name: SILDENAFIL CITRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216383
Product Number: 001
Approval Date: Aug 29, 2023
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SILDENAFIL CITRATE (SILDENAFIL CITRATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: SILDENAFIL CITRATE
Proprietary Name: SILDENAFIL CITRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216383
Product Number: 002
Approval Date: Aug 29, 2023
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SILDENAFIL CITRATE (SILDENAFIL CITRATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: SILDENAFIL CITRATE
Proprietary Name: SILDENAFIL CITRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216383
Product Number: 003
Approval Date: Aug 29, 2023
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information