Last Updated: August 2, 2026

Details for New Drug Application (NDA): 210329

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NDA 210329 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, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, Jubilant Generics, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Pharmobedient, 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-one NDAs. It is available from forty-seven 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. Fifty suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

Summary for 210329

Tradename:	TADALAFIL
Applicant:	Jubilant Generics
Ingredient:	tadalafil
Patents:	0

Medical Subject Heading (MeSH) Categories for 210329

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 15, 2026	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 15, 2026	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 15, 2026	TE:	AB1	RLD:	No

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