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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090141

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NDA 090141 describes TADALAFIL, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, Qilu Pharm Co Ltd, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms, and is included in twenty-nine NDAs. It is available from thirty-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. Thirty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 090141
Tradename:TADALAFIL
Applicant:Teva Pharms Usa
Ingredient:tadalafil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090141
Medical Subject Heading (MeSH) Categories for 090141
Suppliers and Packaging for NDA: 090141
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TADALAFIL tadalafil TABLET;ORAL 090141 ANDA Teva Pharmaceuticals USA, Inc. 0093-3016 0093-3016-65 2 BLISTER PACK in 1 BOX (0093-3016-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3016-30)
TADALAFIL tadalafil TABLET;ORAL 090141 ANDA Teva Pharmaceuticals USA, Inc. 0093-3017 0093-3017-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-3017-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:May 22, 2018TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 26, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 22, 2018TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 26, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 22, 2018TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 26, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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