Last Updated: May 27, 2026

Details for New Drug Application (NDA): 215708

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NDA 215708 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 sixty 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-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 215708

Tradename:	SILDENAFIL CITRATE
Applicant:	Zydus Lifesciences
Ingredient:	sildenafil citrate
Patents:	0

Pharmacology for NDA: 215708

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 215708

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 215708

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILDENAFIL CITRATE	sildenafil citrate	FOR SUSPENSION;ORAL	215708	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1716	70710-1716-4	1 BOTTLE, GLASS in 1 CARTON (70710-1716-4) / 112 mL in 1 BOTTLE, GLASS
SILDENAFIL CITRATE	sildenafil citrate	FOR SUSPENSION;ORAL	215708	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1716	70710-1716-5	1 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5) / 112 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 10MG BASE/ML
Approval Date:	Sep 29, 2022	TE:	AB	RLD:	No

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