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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213041


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NDA 213041 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 Lifesciences, 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-five 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-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 213041
Tradename:SILDENAFIL CITRATE
Applicant:Aptapharma Inc
Ingredient:sildenafil citrate
Patents:0
Medical Subject Heading (MeSH) Categories for 213041

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 10MG BASE/ML
Approval Date:Aug 6, 2020TE:ABRLD:No

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