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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205885


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NDA 205885 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hangzhou Binjiang, Hetero Labs Ltd Iii, Hibrow Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty NDAs. It is available from forty-four suppliers. Additional details are available on the TADALAFIL profile page.

The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 205885
Tradename:TADALAFIL
Applicant:Watson Labs Inc
Ingredient:tadalafil
Patents:0
Pharmacology for NDA: 205885
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 205885
Suppliers and Packaging for NDA: 205885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TADALAFIL tadalafil TABLET;ORAL 205885 ANDA Teva Pharmaceuticals, Inc. 0480-2309 0480-2309-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-2309-56)
TADALAFIL tadalafil TABLET;ORAL 205885 ANDA Teva Pharmaceuticals, Inc. 0480-2310 0480-2310-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-2310-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 29, 2019TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 29, 2019TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 29, 2019TE:AB1RLD:No

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