Last Updated: September 28, 2026

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, Aurobindo Pharma Ltd, Chartwell Rx, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin, MSN, Novitium Pharma, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, Cadila Pharms Ltd, Jubilant Generics, Macleods Pharms, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon Research, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in forty-nine 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 is one drug master file entry for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 213041

Tradename:	SILDENAFIL CITRATE
Applicant:	Invagen Pharms
Ingredient:	sildenafil citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 213041

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 10MG BASE/ML
Approval Date:	Aug 6, 2020	TE:	AB	RLD:	No

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