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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 202503

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NDA 202503 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 Ltd, 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 Ltd, 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 fifty-three 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. Fifty-six suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 202503

Tradename:	SILDENAFIL CITRATE
Applicant:	Watson Labs Inc
Ingredient:	sildenafil citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 202503

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Nov 6, 2012	TE:	AB	RLD:	No

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