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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 211534

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NDA 211534 describes SILDENAFIL CITRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Appco, Aptapharma Inc, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Lupin Ltd, MSN, Novitium Pharma, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in forty-seven NDAs. It is available from sixty-five 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-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 211534

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

Pharmacology for NDA: 211534

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 211534

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 211534

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILDENAFIL CITRATE	sildenafil citrate	FOR SUSPENSION;ORAL	211534	ANDA	Actavis Pharma, Inc.	0591-4050	0591-4050-94	1 BOTTLE in 1 CARTON (0591-4050-94) / 112 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 10MG BASE/ML
Approval Date:	May 29, 2020	TE:	AB	RLD:	No

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