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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 212440


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NDA 212440 describes SILDENAFIL CITRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin Ltd, MSN, Novitium Pharma, Somerset Theraps Llc, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, 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 212440
Tradename:SILDENAFIL CITRATE
Applicant:Alkem Labs Ltd
Ingredient:sildenafil citrate
Patents:0
Pharmacology for NDA: 212440
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 212440
Suppliers and Packaging for NDA: 212440
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate FOR SUSPENSION;ORAL 212440 ANDA Ascend Laboratories, LLC 67877-648 67877-648-11 1 BOTTLE, GLASS in 1 CARTON (67877-648-11) / 112 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 10MG BASE/ML
Approval Date:Nov 27, 2019TE:ABRLD:No

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