BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Farmers Insurance
US Department of Justice
Express Scripts
Federal Trade Commission

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203963

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NDA 203963 describes SILDENAFIL CITRATE, which is a drug marketed by Watson Labs Inc, Macleods Pharms Ltd, Hetero Labs Ltd V, Amneal Pharms, Teva, Actavis Grp Ptc, Mylan Pharms Inc, Aurobindo Pharma Ltd, Apotex Corp, Torrent Pharms Ltd, Teva Pharms, Rubicon Res Pvt Ltd, and Dr Reddys Labs Ltd, and is included in fourteen NDAs. It is available from twenty-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. Thirty-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for NDA: 203963

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203963

Suppliers and Packaging for NDA: 203963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sildenafil citrate
TABLET;ORAL 203963 ANDA Aidarex Pharmaceuticals LLC 53217-293 53217-293-10 10 TABLET, FILM COATED in 1 BOTTLE (53217-293-10)
sildenafil citrate
TABLET;ORAL 203963 ANDA Aidarex Pharmaceuticals LLC 53217-293 53217-293-90 90 TABLET, FILM COATED in 1 BOTTLE (53217-293-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 18, 2015TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Fish and Richardson
US Army

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