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Last Updated: October 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203962

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NDA 203962 describes SILDENAFIL CITRATE, which is a drug marketed by Novitium Pharma, Aurobindo Pharma Ltd, Actavis Grp Ptc, Ajanta Pharma Ltd, Amneal Pharms, Amneal Pharms Ny, Apotex Corp, Hebei Changshan, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Rubicon, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, and Watson Labs Inc, and is included in twenty-four NDAs. It is available from forty-three 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. Forty-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 203962
Tradename:SILDENAFIL CITRATE
Applicant:Aurobindo Pharma Ltd
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203962
Medical Subject Heading (MeSH) Categories for 203962
Suppliers and Packaging for NDA: 203962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203962 ANDA Aurobindo Pharma Limited 65862-689 65862-689-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-689-01)
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203962 ANDA Aurobindo Pharma Limited 65862-689 65862-689-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-689-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 11, 2018TE:ABRLD:No

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