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Healthtrust
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204883

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NDA 204883 describes SILDENAFIL CITRATE, which is a drug marketed by Aurobindo Pharma Ltd, Actavis Grp Ptc, Amneal Pharms, Apotex Corp, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan Pharms Inc, Rubicon Res Pvt Ltd, Teva, Teva Pharms, Torrent Pharms Ltd, and Watson Labs Inc, and is included in fourteen NDAs. It is available from twenty-eight 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-seven suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 204883

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204883

Medical Subject Heading (MeSH) Categories for 204883

Suppliers and Packaging for NDA: 204883

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 204883 ANDA Vensun Pharmaceuticals, Inc. 42543-005 42543-005-90 90 TABLET, FILM COATED in 1 BOTTLE (42543-005-90)
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 204883 ANDA Vensun Pharmaceuticals, Inc. 42543-005 42543-005-10 1000 TABLET, FILM COATED in 1 BOTTLE (42543-005-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 20, 2016TE:ABRLD:No


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