Product Details for ANDA 091448
SILDENAFIL CITRATE (SILDENAFIL CITRATE)
EQ 25MG BASE
Marketing Status: Prescription
EQ 50MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
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: A091448
Product Number: 001
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
SILDENAFIL CITRATE (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: A091448
Product Number: 001
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A091448
Product Number: 002
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
SILDENAFIL CITRATE (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: A091448
Product Number: 002
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A091448
Product Number: 003
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A091448
Product Number: 003
Approval Date: Jun 11, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information