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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 078380

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NDA 078380 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-six 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-one suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 078380

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

Pharmacology for NDA: 078380

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 078380

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 078380

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	078380	ANDA	Proficient Rx LP	71205-509	71205-509-30	30 TABLET, FILM COATED in 1 BOTTLE (71205-509-30)
SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	078380	ANDA	Proficient Rx LP	71205-509	71205-509-60	60 TABLET, FILM COATED in 1 BOTTLE (71205-509-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 7, 2013	TE:	AB	RLD:	No

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