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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 217606


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NDA 217606 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-five 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-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 217606
Tradename:TADALAFIL
Applicant:Hibrow Hlthcare
Ingredient:tadalafil
Patents:0
Pharmacology for NDA: 217606
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 217606
Suppliers and Packaging for NDA: 217606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TADALAFIL tadalafil TABLET;ORAL 217606 ANDA FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED 82968-001 82968-001-03 2 BLISTER PACK in 1 CARTON (82968-001-03) / 15 TABLET, FILM COATED in 1 BLISTER PACK
TADALAFIL tadalafil TABLET;ORAL 217606 ANDA FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED 82968-002 82968-002-01 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 13, 2024TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 13, 2024TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 13, 2024TE:AB1RLD:No

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