Last Updated: September 24, 2026

Details for New Drug Application (NDA): 201156

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NDA 201156 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 201156

Tradename:	SILDENAFIL CITRATE
Applicant:	Jubilant Generics
Ingredient:	sildenafil citrate
Patents:	0

Pharmacology for NDA: 201156

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 201156

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 201156

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	201156	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-434	59746-434-03	100 TABLET, FILM COATED in 1 CARTON (59746-434-03)
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	201156	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-434	59746-434-04	10 TABLET, FILM COATED in 1 BLISTER PACK (59746-434-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Dec 20, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Dec 20, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 20, 2024	TE:	AB	RLD:	No

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