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Last Updated: February 24, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202659


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NDA 202659 describes SILDENAFIL CITRATE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Novitium Pharma, Aurobindo Pharma Ltd, Actavis Grp Ptc, 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-seven NDAs. It is available from thirty-nine 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-four suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 202659
Tradename:SILDENAFIL CITRATE
Applicant:Hetero Labs Ltd V
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202659
Medical Subject Heading (MeSH) Categories for 202659
Suppliers and Packaging for NDA: 202659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202659 ANDA Camber Pharmaceuticals, Inc. 31722-709 31722-709-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-709-05)
SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202659 ANDA Camber Pharmaceuticals, Inc. 31722-709 31722-709-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-709-30)

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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