Last Updated: May 4, 2026

Details for New Drug Application (NDA): 209302

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NDA 209302 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-seven 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-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 209302

Tradename:	SILDENAFIL CITRATE
Applicant:	Umedica
Ingredient:	sildenafil citrate
Patents:	0

Pharmacology for NDA: 209302

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 209302

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 209302

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	209302	ANDA	A-S Medication Solutions	50090-7181	50090-7181-0	10 TABLET in 1 BOTTLE (50090-7181-0)
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	209302	ANDA	Preferred Pharmaceuticals Inc.	68788-8804	68788-8804-1	10 TABLET in 1 BOTTLE (68788-8804-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Aug 25, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Aug 25, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jun 15, 2021	TE:	AB	RLD:	No

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