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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091448


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NDA 091448 describes SILDENAFIL CITRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Appco, Aptapharma Inc, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Lupin Ltd, MSN, Novitium Pharma, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in forty-seven NDAs. It is available from sixty suppliers. Additional details are available on the SILDENAFIL CITRATE profile page.

The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 091448
Tradename:SILDENAFIL CITRATE
Applicant:Torrent
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091448
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 091448
Suppliers and Packaging for NDA: 091448
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 091448 ANDA Torrent Pharmaceuticals Limited 13668-186 13668-186-01 100 TABLET, FILM COATED in 1 BOTTLE (13668-186-01)
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 091448 ANDA Torrent Pharmaceuticals Limited 13668-186 13668-186-05 500 TABLET, FILM COATED in 1 BOTTLE (13668-186-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

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