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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203623


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NDA 203623 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, 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 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-three suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 203623
Tradename:SILDENAFIL CITRATE
Applicant:Hetero Labs Ltd V
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203623
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 203623
Suppliers and Packaging for NDA: 203623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203623 ANDA Camber Pharmaceuticals, Inc. 31722-776 31722-776-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-776-05)
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203623 ANDA Camber Pharmaceuticals, Inc. 31722-776 31722-776-31 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-776-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 26, 2014TE:ABRLD:No

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